Trial Outcomes & Findings for Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB) (NCT NCT01125722)
NCT ID: NCT01125722
Last Updated: 2012-12-17
Results Overview
Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
COMPLETED
NA
74 participants
From baseline to Week 4 of active treatment
2012-12-17
Participant Flow
Participant milestones
| Measure |
Investigator Placement Group
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
34
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Investigator Placement Group
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)
Baseline characteristics by cohort
| Measure |
Investigator Placement Group
n=37 Participants
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
n=37 Participants
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age Continuous
|
59.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
28 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 4 of active treatmentPopulation: Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.
Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Outcome measures
| Measure |
Investigator Placement Group
n=32 Participants
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
n=37 Participants
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
|---|---|---|
|
Change in Mean Daily Urgency Incontinence Episodes
|
-2.5 number of incontinence episodes/24 hours
Standard Deviation 3.05
|
-2.5 number of incontinence episodes/24 hours
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: From baseline to Week 4 of active treatmentPopulation: Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.
Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Outcome measures
| Measure |
Investigator Placement Group
n=32 Participants
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
n=37 Participants
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
|---|---|---|
|
Change in Mean Daily Voiding Frequency
|
-1.8 number of voids per 24 hours
Standard Deviation 2.13
|
-1.6 number of voids per 24 hours
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: From Baseline to Week 4 of active treatmentPopulation: Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.
Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Outcome measures
| Measure |
Investigator Placement Group
n=32 Participants
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
n=37 Participants
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
|---|---|---|
|
Change in Mean Volume Per Void
|
5.3 mL
Standard Deviation 26.37
|
10.5 mL
Standard Deviation 57.01
|
SECONDARY outcome
Timeframe: From Baseline to Week 4 of active treatmentPopulation: Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.
Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.
Outcome measures
| Measure |
Investigator Placement Group
n=32 Participants
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
n=37 Participants
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
|---|---|---|
|
Change in Mean Urgency Episodes Per Day
|
-2.1 number of urgency episodes per 24 hours
Standard Deviation 2.47
|
-2.1 number of urgency episodes per 24 hours
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: From Baseline to Week 4 of active treatmentPopulation: Modified Intent-to-Treat Set (Full Analysis Set) - defined as all eligible subjects who were randomized to one of the two treatment arms and received some treatment.
The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above.
Outcome measures
| Measure |
Investigator Placement Group
n=32 Participants
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
n=37 Participants
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
|---|---|---|
|
Change in Mean Overactive Bladder Symptom Composite Score
|
-11.7 scores on a scale
Standard Deviation 16.52
|
-11.7 scores on a scale
Standard Deviation 14.58
|
Adverse Events
Investigator Placement Group
Subject Placement Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigator Placement Group
n=37 participants at risk
Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
|
Subject Placement Group
n=37 participants at risk
Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
37.8%
14/37 • Number of events 27
|
32.4%
12/37 • Number of events 22
|
|
Nervous system disorders
Sensory/Peripheral Neurological Effect
|
8.1%
3/37 • Number of events 4
|
8.1%
3/37 • Number of events 3
|
|
Renal and urinary disorders
Urinary Tract Reactions
|
5.4%
2/37 • Number of events 3
|
2.7%
1/37 • Number of events 1
|
Additional Information
Michael Schwiers, Principal Biostatistician
Ethicon Endo-Surgery
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place