Trial Outcomes & Findings for Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA) (NCT NCT01502956)
NCT ID: NCT01502956
Last Updated: 2018-05-02
Results Overview
The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
386 participants
Primary outcome timeframe
6 Months
Results posted on
2018-05-02
Participant Flow
Women who have persistent severe UUI symptoms, defined as ≥6 UUI episodes on a 3-day bladder diary are recruited from urology and urogynecology subspecialty clinics as well as by other marketing methods.
Participant milestones
| Measure |
InterStim® Device
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
InterStim® device: Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be d
|
Botox® Injection
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Botox® injection: Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC.
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
194
|
|
Overall Study
COMPLETED
|
168
|
168
|
|
Overall Study
NOT COMPLETED
|
24
|
26
|
Reasons for withdrawal
| Measure |
InterStim® Device
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
InterStim® device: Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be d
|
Botox® Injection
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Botox® injection: Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC.
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
14
|
11
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
10
|
Baseline Characteristics
Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)
Baseline characteristics by cohort
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
Total
n=364 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Age, Customized
Age <65 years
|
91 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Age, Customized
Age => 65 years
|
83 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
174 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
160 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
327 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
149 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Menopausal Status
Pre-menopausal
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Menopausal Status
Post-menopausal
|
149 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
|
Menopausal Status
Not sure
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
History of Recurrent UTIs
No history of recurrent UTIs
|
149 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
History of Recurrent UTIs
History of recurrent UTIs
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Urinary Incontinence Episodes Per Day
Total incontinence episodes per day
|
5.8 Episodes per day
STANDARD_DEVIATION 3.0 • n=5 Participants
|
6.0 Episodes per day
STANDARD_DEVIATION 3.0 • n=7 Participants
|
5.9 Episodes per day
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Urinary Incontinence Episodes Per Day
Urge incontinence episodes per day
|
5.2 Episodes per day
STANDARD_DEVIATION 2.7 • n=5 Participants
|
5.4 Episodes per day
STANDARD_DEVIATION 2.7 • n=7 Participants
|
5.3 Episodes per day
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Nocturia (number of night voids per day)
|
1.7 Voids per day
STANDARD_DEVIATION 1.4 • n=5 Participants
|
1.7 Voids per day
STANDARD_DEVIATION 1.2 • n=7 Participants
|
1.7 Voids per day
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Overactive Bladder Questionnaire - Short Form (OABq-SF)
OABq-SF Symptom Bother
|
76.1 units on a scale
STANDARD_DEVIATION 16.8 • n=5 Participants
|
74.6 units on a scale
STANDARD_DEVIATION 19.5 • n=7 Participants
|
75.3 units on a scale
STANDARD_DEVIATION 18.3 • n=5 Participants
|
|
Overactive Bladder Questionnaire - Short Form (OABq-SF)
OABq-SF Quality of Life
|
36.8 units on a scale
STANDARD_DEVIATION 21.6 • n=5 Participants
|
38.2 units on a scale
STANDARD_DEVIATION 23.0 • n=7 Participants
|
37.5 units on a scale
STANDARD_DEVIATION 22.3 • n=5 Participants
|
|
Urinary Frequency and Nocturia - Sandvik Questionnaire
Slight
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Urinary Frequency and Nocturia - Sandvik Questionnaire
Moderate
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Urinary Frequency and Nocturia - Sandvik Questionnaire
Severe
|
38 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Urinary Frequency and Nocturia - Sandvik Questionnaire
Very Severe
|
105 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Urinary Distress Inventory Short Form (UDI-SF)
|
59.2 units on a scale
STANDARD_DEVIATION 16.9 • n=5 Participants
|
60.9 units on a scale
STANDARD_DEVIATION 18.3 • n=7 Participants
|
60.1 units on a scale
STANDARD_DEVIATION 17.7 • n=5 Participants
|
|
Incontinence Impact Questionnaire Short Form (IIQ-SF)
|
52.5 units on a scale
STANDARD_DEVIATION 25.8 • n=5 Participants
|
52.7 units on a scale
STANDARD_DEVIATION 27.6 • n=7 Participants
|
52.6 units on a scale
STANDARD_DEVIATION 26.7 • n=5 Participants
|
|
Health Utilities Index Mark 3 (HUI-3)
|
0.74 units on a scale
STANDARD_DEVIATION 0.28 • n=5 Participants
|
0.71 units on a scale
STANDARD_DEVIATION 0.30 • n=7 Participants
|
0.73 units on a scale
STANDARD_DEVIATION 0.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 post-baseline diary assessment.
The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period.
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Number of Urge Urinary Incontinence (UUI) Episodes
|
-3.25 UUI episodes
Interval -3.64 to -2.87
|
-3.89 UUI episodes
Interval -4.26 to -3.52
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 postbaseline diary assessment.
Proportion of subjects who report adequate improvement of their bladder function and urinary leakage with the Patient Global Impression of Improvement Questionnaire (PGI-I) at 6 months. Adequate improvement is defined as a rating of 1, 2, or 3 (better) on the patient-reported measure of perceived improvement with treatment on a scale of 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Number of Participants With Improvement of Bladder Function and Urinary Leakage
Urinary leakage
|
91 Participants
|
101 Participants
|
|
Number of Participants With Improvement of Bladder Function and Urinary Leakage
Bladder function
|
92 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 post-baseline diary assessment.
Change in mean Overactive Bladder Questionnaire Short Form (OABq-SF) score throughout baseline to the first 6-month visit (1, 2, 3, 4, 5, and 6-month assessments). Values range from 0 to 100 with higher scores on the symptom scale indicating greater severity of symptoms and higher scores on the quality of life scale indicating a better quality of life.
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Change in Overactive Bladder
OABq-SF Symptom Bother
|
-38.6 units on a scale
Interval -42.5 to -34.6
|
-46.7 units on a scale
Interval -50.5 to -43.0
|
|
Change in Overactive Bladder
OABq-SF Quality of Life
|
38.1 units on a scale
Interval 34.1 to 42.0
|
41.6 units on a scale
Interval 37.9 to 45.4
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 post-baseline diary assessment.
Change in mean number of urinary incontinence episodes (any type) and nocturia episodes from baseline over the first 6-month visit period (1, 2, 3, 4, 5, and 6-month assessments) as measured by the 3 day bladder diary.
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Urinary Frequency and Nocturia
Incontinence episodes (any)
|
-3.50 Number of episodes
Interval -3.94 to -3.06
|
-4.02 Number of episodes
Interval -4.44 to -3.61
|
|
Urinary Frequency and Nocturia
Nocturia episodes
|
-0.26 Number of episodes
Interval -0.43 to -0.1
|
-0.40 Number of episodes
Interval -0.56 to -0.24
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 post-baseline diary assessment.
Severity of urge incontinence symptoms at 6 month visit period as measured by the Sandvik questionnaire. The Sandvik score is a patient-reported measure of incontinence severity as assessed on a scale of slight (1-2), moderate (3-6), severe (8-9), very severe (12) to severe (10-12) using a standard scoring algorithm.
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Severity of Urge Incontinence Symptoms
Sandvik Slight
|
23 Participants
|
29 Participants
|
|
Severity of Urge Incontinence Symptoms
Sandvik Moderate
|
33 Participants
|
33 Participants
|
|
Severity of Urge Incontinence Symptoms
Sandvik Severe
|
24 Participants
|
28 Participants
|
|
Severity of Urge Incontinence Symptoms
Sandvik Very Severe
|
44 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All eligible participants who provided at least 1 post-baseline diary assessment.
Treatment satisfaction as measured by the mean Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) score at 6 months (6 month assessment). The OAB-SATq score ranges from 0 to 100 and includes 5 subscales: treatment satisfaction, side effects, treatment endorsement, convenience, and treatment preference, with higher scores reflecting better satisfaction.
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)
OAB-SATq Treatment Satisfaction
|
59.8 units on a scale
Interval 55.0 to 64.7
|
67.7 units on a scale
Interval 63.2 to 72.1
|
|
Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)
OAB-SATq Adverse Effects
|
85.1 units on a scale
Interval 81.1 to 89.2
|
88.4 units on a scale
Interval 84.7 to 92.2
|
|
Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)
OAB-SATq Endorsement
|
67.6 units on a scale
Interval 62.9 to 72.3
|
78.1 units on a scale
Interval 73.7 to 82.4
|
|
Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)
OAB-SATq Convenience
|
70.2 units on a scale
Interval 65.8 to 74.5
|
67.6 units on a scale
Interval 63.7 to 71.6
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 postbaseline diary assessment.
Treatment preference as measured by the Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) at 6 months (6 month assessment).OAB-SATq treatment preference is a binary outcome that is classified as yes if a participant answers either "Slight preference for the treatment I am receiving now" or "Definitely prefer the treatment I am receiving now" to the question "Do you prefer the treatment that you received since entering this study to the treatment you received before the study?"
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Treatment Satisfaction (OAB-SATq Treatment Preference)
|
89 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 post-baseline diary assessment.
Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in mean Urinary Distress Inventory Short Form (UDI-SF) score. The UDI-SF scale has a range from 0 to 100 with higher scores indicating greater distress.
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Quality of Life (UDI-SF)
|
-8.6 units on a scale
Interval -10.9 to -6.3
|
-10.0 units on a scale
Interval -12.2 to -7.8
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 post-baseline diary assessment.
Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in the mean Incontinence Impact Questionnaire short form (IIQ-SF) score. The IIQ-SF scale has a range from 0 to 100 with higher scores indicating a worse quality of life.
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Quality of Life (IIQ-SF)
|
-10.4 units on a scale
Interval -13.0 to -7.8
|
-12.4 units on a scale
Interval -14.9 to -9.9
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All eligible participants who provided at least 1 post-baseline diary assessment.
Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the Health Utility Index, Version 3 (HUI-3). The HUI 3 scale has a range from 0 to 1 with higher scores representing better health.
Outcome measures
| Measure |
InterStim® Device
n=174 Participants
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=190 Participants
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Quality of Life (HUI-3)
|
-0.006 units on a scale
Interval -0.025 to 0.013
|
-0.011 units on a scale
Interval -0.028 to 0.007
|
Adverse Events
InterStim® Device
Serious events: 58 serious events
Other events: 20 other events
Deaths: 0 deaths
Botox® Injection
Serious events: 58 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
InterStim® Device
n=178 participants at risk
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=191 participants at risk
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Infections and infestations
Abscess
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Cellulitis
|
1.7%
3/178 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Clostridium difficile infection
|
1.1%
2/178 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Device related infection
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Epiglottitis
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Incision site infection
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Influenza
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Meningitis viral
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Parotitis
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Pneumonia
|
1.7%
3/178 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Post procedural infection
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Sepsis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
2.1%
4/191 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Subcutaneous abscess
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Wound infection
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Anal sphincterotomy
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Appendicectomy
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Cardiac operation
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Endotracheal intubation
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Gastrectomy
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Gastric bypass
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Hernia hiatus repair
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Hysterectomy
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Intestinal resection
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Knee operation
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Mammoplasty
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Medical device change
|
1.1%
2/178 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Medical device removal
|
1.7%
3/178 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Skin graft
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Tenotomy
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Fall
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.6%
3/191 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Dementia
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Loss of consciousness
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Radiculopathy
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Seizure
|
1.1%
2/178 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Syncope
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.1%
2/178 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Angina pectoris
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
3/178 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Bradycardia
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Cardiac arrest
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Myocardial infarction
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
4/178 • Number of events 5 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.6%
3/191 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Ileus
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Intestinal cyst
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Oesophageal mass
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Chest pain
|
1.1%
2/178 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
1.0%
2/191 • Number of events 2 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Device deployment issue
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Device dislocation
|
1.7%
3/178 • Number of events 3 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Hernia
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Medical device site pain
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
2.1%
4/191 • Number of events 4 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Psychiatric disorders
Agitation
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Psychiatric disorders
Depression
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Psychiatric disorders
Mental status changes
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Metabolism and nutrition disorders
Obesity
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Renal and urinary disorders
Renal failure
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Renal and urinary disorders
Urinary retention
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/178 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.52%
1/191 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Investigations
Cyst aspiration
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Social circumstances
Sexual abuse
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Vascular disorders
Lymphoedema
|
0.56%
1/178 • Number of events 1 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/191 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
Other adverse events
| Measure |
InterStim® Device
n=178 participants at risk
The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/\>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.
|
Botox® Injection
n=191 participants at risk
Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
11.2%
20/178 • Number of events 28 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
34.6%
66/191 • Number of events 107 • Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place