Trial Outcomes & Findings for Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder (NCT NCT00821184)
NCT ID: NCT00821184
Last Updated: 2018-04-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
12 participants
Primary outcome timeframe
0 week - 12 weeks
Results posted on
2018-04-04
Participant Flow
Participant milestones
| Measure |
Vesicare Alone
Vesicare alone in treatment of incontinence
|
Vesicare Plus Behavioral Modification
Vesicare plus behavioral modification for treatment of incontinence
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
Baseline characteristics by cohort
| Measure |
Vesicare Alone
n=6 Participants
Vesicare alone in treatment of incontinence
|
Vesicare Plus Behavioral Modification
n=6 Participants
Vesicare plus behavioral modification for treatment of incontinence
|
Total
n=12 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 week - 12 weeksOutcome measures
| Measure |
Vesicare Alone
n=6 Participants
Vesicare alone in treatment of incontinence
|
Vesicare Plus Behavioral Modification
n=6 Participants
Vesicare plus behavioral modification for treatment of incontinence
|
|---|---|---|
|
Change From Baseline in the Number of Incontinence Episodes Per 24 Hours Measured by Voiding Diaries.
|
1 incontinence episodes per 24 hours
Interval 0.0 to 5.0
|
10 incontinence episodes per 24 hours
Interval 2.0 to 22.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Vesicare Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vesicare Plus Behavioral Modification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place