Trial Outcomes & Findings for InSite for Over Active Bladder (NCT NCT00547378)
NCT ID: NCT00547378
Last Updated: 2017-12-12
Results Overview
To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as: * at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or * at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (\<8 voids/day) for subjects with urgency-frequency at baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
571 participants
Primary outcome timeframe
6 months
Results posted on
2017-12-12
Participant Flow
Thirty-eight centers were activated to enroll subjects. In total, 571 subjects were enrolled: 243 randomized cohort (96 excluded due to eligibility failure); 328 non-randomized cohort (102 excluded due to declined to participate; did not meet inclusion criteria and other). Subjects were enrolled between November 2007 and March 10, 2011.
The study has 2 cohorts. The randomized cohort included subjects who were randomized 1:1 to either InterStim Therapy (IST) or Standard Medical Therapy (SMT) and were followed for 6 months. The all implanted cohort include implanted subjects from the randomized cohort plus additional subjects enrolled after randomized cohort enrollment completion.
Participant milestones
| Measure |
InterStim Therapy
Randomized Cohort - InterStim Therapy. This includes those subjects who were randomized to InterStim Therapy.
|
Standard Medical Therapy
Randomized Cohort - Standard Medical Therapy. This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant.
|
All Implanted/Non-Randomized Cohort
These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system.
|
|---|---|---|---|
|
Randomized Cohort
STARTED
|
70
|
77
|
0
|
|
Randomized Cohort
Month 3
|
62
|
72
|
0
|
|
Randomized Cohort
Month 6
|
59
|
71
|
0
|
|
Randomized Cohort
COMPLETED
|
59
|
71
|
0
|
|
Randomized Cohort
NOT COMPLETED
|
11
|
6
|
0
|
|
All Implanted Cohort
STARTED
|
51
|
40
|
181
|
|
All Implanted Cohort
Month 3
|
51
|
39
|
178
|
|
All Implanted Cohort
Month 6
|
50
|
36
|
178
|
|
All Implanted Cohort
Month 12
|
48
|
32
|
175
|
|
All Implanted Cohort
Month 24
|
42
|
30
|
161
|
|
All Implanted Cohort
Month 36
|
42
|
29
|
146
|
|
All Implanted Cohort
Month 48
|
38
|
27
|
136
|
|
All Implanted Cohort
Month 60
|
36
|
23
|
114
|
|
All Implanted Cohort
COMPLETED
|
36
|
22
|
111
|
|
All Implanted Cohort
NOT COMPLETED
|
15
|
18
|
70
|
Reasons for withdrawal
| Measure |
InterStim Therapy
Randomized Cohort - InterStim Therapy. This includes those subjects who were randomized to InterStim Therapy.
|
Standard Medical Therapy
Randomized Cohort - Standard Medical Therapy. This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant.
|
All Implanted/Non-Randomized Cohort
These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system.
|
|---|---|---|---|
|
Randomized Cohort
Withdrawal by Subject
|
7
|
5
|
0
|
|
Randomized Cohort
Death
|
0
|
1
|
0
|
|
Randomized Cohort
Lost to Follow-up
|
1
|
0
|
0
|
|
Randomized Cohort
Adverse Event
|
1
|
0
|
0
|
|
Randomized Cohort
Other reasons
|
2
|
0
|
0
|
|
All Implanted Cohort
Withdrawal by Subject
|
5
|
4
|
27
|
|
All Implanted Cohort
Adverse Event
|
4
|
10
|
17
|
|
All Implanted Cohort
Lost to Follow-up
|
0
|
1
|
14
|
|
All Implanted Cohort
Death
|
3
|
1
|
4
|
|
All Implanted Cohort
Physician Decision
|
0
|
2
|
6
|
|
All Implanted Cohort
Site closure
|
2
|
0
|
1
|
|
All Implanted Cohort
Other reasons
|
1
|
0
|
1
|
Baseline Characteristics
Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
Baseline characteristics by cohort
| Measure |
Randomized Cohort: InterStim Therapy
n=70 Participants
This includes those subjects who were randomized to InterStim Therapy.
|
Randomized Cohort: Standard Medical Therapy
n=77 Participants
This includes subjects who were randomized to Standard Medical Therapy. After being followed at SMT Month 6, these subjects could choose to receive test stimulation and if successful, received full system implant.
|
All Implanted Cohort: Non-randomized Subjects
n=181 Participants
These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system.
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age, years
|
60.4 years
STANDARD_DEVIATION 14.4 • n=70 Participants
|
57.1 years
STANDARD_DEVIATION 15.3 • n=77 Participants
|
57.2 years
STANDARD_DEVIATION 14.1 • n=181 Participants
|
57.9 years
STANDARD_DEVIATION 14.5 • n=328 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=70 Participants
|
71 Participants
n=77 Participants
|
165 Participants
n=181 Participants
|
302 Participants
n=328 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=70 Participants
|
6 Participants
n=77 Participants
|
16 Participants
n=181 Participants
|
26 Participants
n=328 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=70 Participants
|
0 Participants
n=77 Participants
|
8 Participants
n=181 Participants
|
11 Participants
n=328 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=70 Participants
|
77 Participants
n=77 Participants
|
173 Participants
n=181 Participants
|
317 Participants
n=328 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=70 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=181 Participants
|
0 Participants
n=328 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
61 Participants
n=70 Participants
|
70 Participants
n=77 Participants
|
161 Participants
n=181 Participants
|
292 Participants
n=328 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
7 Participants
n=70 Participants
|
7 Participants
n=77 Participants
|
12 Participants
n=181 Participants
|
26 Participants
n=328 Participants
|
|
Race/Ethnicity, Customized
Race · Asian/White
|
1 Participants
n=70 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=181 Participants
|
1 Participants
n=328 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native/White
|
0 Participants
n=70 Participants
|
0 Participants
n=77 Participants
|
2 Participants
n=181 Participants
|
2 Participants
n=328 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=70 Participants
|
0 Participants
n=77 Participants
|
1 Participants
n=181 Participants
|
1 Participants
n=328 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=70 Participants
|
0 Participants
n=77 Participants
|
1 Participants
n=181 Participants
|
1 Participants
n=328 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=70 Participants
|
0 Participants
n=77 Participants
|
4 Participants
n=181 Participants
|
5 Participants
n=328 Participants
|
|
Baseline Leaks/Day
|
2.4 Leaks/Day
STANDARD_DEVIATION 1.7 • n=51 Participants • Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
|
2.7 Leaks/Day
STANDARD_DEVIATION 1.9 • n=61 Participants • Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
|
3.4 Leaks/Day
STANDARD_DEVIATION 3.0 • n=138 Participants • Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
|
3.0 Leaks/Day
STANDARD_DEVIATION 2.6 • n=250 Participants • Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
|
|
Baseline Voids/Day
|
11.2 Voids/Day
STANDARD_DEVIATION 2.9 • n=45 Participants • Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
|
11.9 Voids/Day
STANDARD_DEVIATION 4.3 • n=50 Participants • Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
|
13.1 Voids/Day
STANDARD_DEVIATION 4.8 • n=134 Participants • Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
|
12.5 Voids/Day
STANDARD_DEVIATION 4.5 • n=229 Participants • Leaks and voids include only those subjects who qualified for Urinary Urge Incontinence (leaks) or Urgency Frequency (voids) at baseline as demonstrated on a 3-day voiding diary demonstrating greater than or equal to 8 voids per day and/or by having a minimum of 2 involuntary leaking episodes in 72 hours. A subject could qualify for both.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent-to-Treat (ITT): an analysis that includes all randomized subjects. This was analysis in the randomized cohort.
To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as: * at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or * at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (\<8 voids/day) for subjects with urgency-frequency at baseline.
Outcome measures
| Measure |
InterStim Therapy
n=70 Participants
Subjects who were randomized to InterStim Therapy group
|
Standard Medical Therapy
n=77 Participants
Subjects who were randomized to Standard Medical Therapy group
|
|---|---|---|
|
Randomized Cohort: OAB Therapeutic Response
|
61 percentage of participants with response
|
42 percentage of participants with response
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: This objective was analyzed in the all implanted cohort.
To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33. Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest.
Outcome measures
| Measure |
InterStim Therapy
n=272 Participants
Subjects who were randomized to InterStim Therapy group
|
Standard Medical Therapy
Subjects who were randomized to Standard Medical Therapy group
|
|---|---|---|
|
All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery
|
0.224 Cumulative probability at 5 years
Interval 0.166 to 0.277
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: This objective was analyzed in the all implanted cohort.
To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. Suspected tined lead migration resulting in an adverse event of lead migration/dislodgement meets the definition of this endpoint.
Outcome measures
| Measure |
InterStim Therapy
n=272 Participants
Subjects who were randomized to InterStim Therapy group
|
Standard Medical Therapy
Subjects who were randomized to Standard Medical Therapy group
|
|---|---|---|
|
All Implanted Cohort: Tined Lead Migration Rate
|
0.059 Cumulative probability at 5 years
Interval 0.029 to 0.089
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: This objective was analyzed in the all implanted cohort.
To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.
Outcome measures
| Measure |
InterStim Therapy
n=272 Participants
Subjects who were randomized to InterStim Therapy group
|
Standard Medical Therapy
Subjects who were randomized to Standard Medical Therapy group
|
|---|---|---|
|
All Implanted Cohort: Infection Rate Associated With the Tined Lead
|
0.012 Cumulative probability at 5 years
Interval 0.0 to 0.025
|
—
|
Adverse Events
Randomized Cohort: InterStim Therapy Group
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Randomized Cohort: Standard Medical Therapy Group
Serious events: 4 serious events
Other events: 22 other events
Deaths: 1 deaths
All Implanted Cohort
Serious events: 107 serious events
Other events: 217 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Randomized Cohort: InterStim Therapy Group
n=51 participants at risk
Adverse events are summarized for those subjects randomized to the InterStim Therapy group and received full system implant (n=51). Out of 70 subjects, there are 11 subjects who were not implanted with any device component, and 8 subjects who were implanted with lead only, but no neurostimulator. These subjects were not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy.
|
Randomized Cohort: Standard Medical Therapy Group
n=75 participants at risk
Adverse events are summarized for those Subjects randomized are compliant to Standard Medical Therapy group (n=75). Out of 77 subjects, 2 subjects crossovered to InterStim Therapy group and received implant. These subjects are not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy.
|
All Implanted Cohort
n=272 participants at risk
The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years.
|
|---|---|---|---|
|
Investigations
Hepatic enzyme abnormal
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/272 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Pyelonephritis
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 4 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Sick sinus syndrome
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Syncope
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Toe deformity
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Vaginal cellulitis
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
2.6%
7/272 • Number of events 8 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.3%
1/75 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/272 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.3%
1/75 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/272 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Pain
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.3%
1/75 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.3%
1/75 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.5%
4/272 • Number of events 5 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
4.4%
12/272 • Number of events 13 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.8%
5/272 • Number of events 12 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.8%
5/272 • Number of events 5 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Chest pain
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.8%
5/272 • Number of events 6 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.5%
4/272 • Number of events 5 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 5 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 5 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 5 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.1%
3/272 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Infection
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Wound infection
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Asthenia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Intentional misuse
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.74%
2/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Catheter bacteraemia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Cystitis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Listeria encephalitis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Sepsis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Skin infection
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Staphylococcal
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Depression
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Dementia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Global amnesia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Headache
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Migraine
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Mononeuropathy multiplex
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Vascular disorders
Aortic disorder
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Rectocele
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Cystocele
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Pregnancy
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Congenital, familial and genetic disorders
Hereditary spastic paraplegia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Hernia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Implant site erosion
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Investigations
Electrocardiogram change
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Investigations
Electroencephalogram abnormal
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Extrusion of device
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Surgical and medical procedures
Intestinal adhesion lysis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.37%
1/272 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
Other adverse events
| Measure |
Randomized Cohort: InterStim Therapy Group
n=51 participants at risk
Adverse events are summarized for those subjects randomized to the InterStim Therapy group and received full system implant (n=51). Out of 70 subjects, there are 11 subjects who were not implanted with any device component, and 8 subjects who were implanted with lead only, but no neurostimulator. These subjects were not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy.
|
Randomized Cohort: Standard Medical Therapy Group
n=75 participants at risk
Adverse events are summarized for those Subjects randomized are compliant to Standard Medical Therapy group (n=75). Out of 77 subjects, 2 subjects crossovered to InterStim Therapy group and received implant. These subjects are not included in this summary. For comparision purpose, adverse events are tabluated between those subjects who received InterStim therapy vs. those who were compliant with Standard Medical Therapy.
|
All Implanted Cohort
n=272 participants at risk
The all implanted cohort included implanted subjects from the initial randomized cohort plus additional subjects enrolled in the study after the randomized cohort enrollment was complete. These additional subjects were not randomized. These non-randomized subjects went through test stimulation and, if successful, were implanted with the InterStim Therapy system. All implanted subjects were followed for 5 years.
|
|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
21.6%
11/51 • Number of events 14 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
4.0%
3/75 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
27.2%
74/272 • Number of events 123 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Undesirable change in stimulation
|
11.8%
6/51 • Number of events 8 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
22.1%
60/272 • Number of events 75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Implant site pain
|
5.9%
3/51 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
14.7%
40/272 • Number of events 55 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
4/51 • Number of events 4 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
2.7%
2/75 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
5.5%
15/272 • Number of events 18 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Sinusitis
|
7.8%
4/51 • Number of events 4 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
2.7%
2/75 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
7.7%
21/272 • Number of events 28 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
3/51 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.3%
1/75 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
12.1%
33/272 • Number of events 39 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
3/51 • Number of events 3 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
2.7%
2/75 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
9.6%
26/272 • Number of events 34 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
5.3%
4/75 • Number of events 4 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.8%
5/272 • Number of events 5 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
9.3%
7/75 • Number of events 7 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
4.8%
13/272 • Number of events 18 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
9.3%
7/75 • Number of events 7 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
7.0%
19/272 • Number of events 25 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Therapeutic product ineffective
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
13.6%
37/272 • Number of events 42 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
9.9%
27/272 • Number of events 31 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Psychiatric disorders
Depression
|
3.9%
2/51 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.3%
1/75 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
9.9%
27/272 • Number of events 30 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
9.2%
25/272 • Number of events 27 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
8.1%
22/272 • Number of events 25 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
2/51 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
7.7%
21/272 • Number of events 28 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Fungal infection
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
7.0%
19/272 • Number of events 25 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
7.0%
19/272 • Number of events 22 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
7.0%
19/272 • Number of events 19 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
6.6%
18/272 • Number of events 19 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
1.3%
1/75 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
6.2%
17/272 • Number of events 19 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
6.2%
17/272 • Number of events 17 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
5.9%
16/272 • Number of events 23 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Renal and urinary disorders
Stress incontinence
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
5.9%
16/272 • Number of events 17 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/51 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
5.5%
15/272 • Number of events 15 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • Number of events 1 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
5.5%
15/272 • Number of events 19 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
|
General disorders
Lead migration/dislodgment
|
3.9%
2/51 • Number of events 2 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
0.00%
0/75 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
5.1%
14/272 • Number of events 17 • Randomization to 6 months follow-up for InterStim arm and Standard Medical Therapy arm in randomized cohort. Implant to 5-year follow up for all implanted cohort.
This section presents the adverse events (regardless device related or otherwise) occurred between randomization and 6 months follow-up in the randomized cohort; and the adverse events (regardless device related or otherwise) occurred post implant through 5-year follow-up for all implanted cohort. The adverse events post implant for InterStim arm subjects in randomized cohort were also included in the adverse events summary of all implanted cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place