Trial Outcomes & Findings for InterStim Therapy Programming Study (NCT NCT01009333)
NCT ID: NCT01009333
Last Updated: 2013-05-27
Results Overview
In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.
COMPLETED
NA
13 participants
three weeks
2013-05-27
Participant Flow
Participant milestones
| Measure |
Start at 5.2 Hz, Then 14 Hz, Then 25 Hz
Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to Medium InterStim Rate Setting at 14 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
|
Start at 5.2 Hz, Then 25 Hz, Then 14 Hz
Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to High InterStim Rate Setting at 25 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
|
Start at 14 Hz, Then 5.2 Hz, Then 25 Hz
Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
|
Start at 14 Hz, Then 25 Hz, Then 5.2 Hz
Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to High InterStim Rate setting at 25 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
|
Start at 25 Hz, Then 5.2 Hz, Then 14 Hz
Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
|
Start at 25 Hz, Then 14 Hz, Then 5.2 Hz
Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Medium InterStim Rate setting at 14 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
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|---|---|---|---|---|---|---|
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Week 1
STARTED
|
2
|
3
|
2
|
2
|
2
|
2
|
|
Week 1
COMPLETED
|
2
|
3
|
2
|
2
|
2
|
2
|
|
Week 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Week 2
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Week 2
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Week 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Week 3
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Week 3
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Week 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
InterStim Therapy Programming Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
61.9 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: three weeksPopulation: Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.
In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.
Outcome measures
| Measure |
Low InterStim Rate Setting at 5.2 Hz
n=12 Participants
|
Medium InterStim Rate Setting at 14 Hz
n=12 Participants
|
High InterStim Rate Setting at 25 Hz
n=12 Participants
|
|---|---|---|---|
|
Number of Urinary Incontinent Episodes Per Day
|
3.83 Episodes Per Day
Standard Deviation 2.27
|
2.37 Episodes Per Day
Standard Deviation 1.83
|
2.82 Episodes Per Day
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: three weeksPopulation: Data from 12 subjects who completed the study were included in the efficacy analysis; data from 1 subject was excluded because the subject was not compliant with the study protocol and was subsequently withdrawn from the study. Data from all 13 subjects were used for safety reporting.
In a diary, subjects are asked clarify each void as 'urine', 'fecal' or 'both'. Either 'urine' or 'both' are counted as void for this analysis. The total number of voids was calculated per day.
Outcome measures
| Measure |
Low InterStim Rate Setting at 5.2 Hz
n=12 Participants
|
Medium InterStim Rate Setting at 14 Hz
n=12 Participants
|
High InterStim Rate Setting at 25 Hz
n=12 Participants
|
|---|---|---|---|
|
Number of Voids Per Day
|
9.33 Voids Per Day
Standard Deviation 2.08
|
9.36 Voids Per Day
Standard Deviation 2.34
|
9.57 Voids Per Day
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: three weeksIn a diary, subjects are asked to provide number of pads they used per day.
Outcome measures
| Measure |
Low InterStim Rate Setting at 5.2 Hz
n=12 Participants
|
Medium InterStim Rate Setting at 14 Hz
n=12 Participants
|
High InterStim Rate Setting at 25 Hz
n=12 Participants
|
|---|---|---|---|
|
Number of Pads Per Day
|
2.61 Pads Per Day
Standard Deviation 1.64
|
1.84 Pads Per Day
Standard Deviation 1.43
|
1.94 Pads Per Day
Standard Deviation 1.61
|
Adverse Events
Low InterStim Rate Setting at 5.2 Hz
Medium InterStim Rate Setting at 14 Hz
High InterStim Rate Setting at 25 Hz
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low InterStim Rate Setting at 5.2 Hz
n=13 participants at risk
|
Medium InterStim Rate Setting at 14 Hz
n=12 participants at risk
|
High InterStim Rate Setting at 25 Hz
n=12 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Renal and urinary disorders
Bladder discomfort
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Change in sensation of stimulation
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Vascular disorders
Hypertension
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Hypertonic bladder
|
15.4%
2/13 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
|
Renal and urinary disorders
Micturition urgency
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Painful defaecation
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/13
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
Additional Information
Maureen McGuire, Sr. Program Manager
Medtronic Neuromodulation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place