Trial Outcomes & Findings for Randomized Trial for Botox Urinary Incontinence (NCT NCT00178191)
NCT ID: NCT00178191
Last Updated: 2011-10-03
Results Overview
number of incontinence episodes/day
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
9 months
Results posted on
2011-10-03
Participant Flow
Recruitment started June, 2005 and completed Dec, 2007
Participant milestones
| Measure |
200 Units Botox
200 units Botulinum-A toxin
|
300 Units Botox
300 units Botulinum-A toxin
|
Placebo
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
7
|
|
Overall Study
COMPLETED
|
11
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial for Botox Urinary Incontinence
Baseline characteristics by cohort
| Measure |
200 Units Botox
n=10 Participants
200 units Botulinum-A toxin
|
300 Units Botox
n=11 Participants
300 units Botulinum-A toxin
|
Placebo
n=7 Participants
Placebo
|
Total
n=28 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
|
0.0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12.0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16.0 Participants
n=4 Participants
|
|
Age Continuous
|
76.20 years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
61.72 years
STANDARD_DEVIATION 13 • n=7 Participants
|
74.14 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
70 years
STANDARD_DEVIATION 13.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28.0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0.0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
7 participants
n=5 Participants
|
28.0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 9 monthsnumber of incontinence episodes/day
Outcome measures
| Measure |
200 Units Botox
n=11 Participants
200 units Botulinum-A toxin
|
300 Units Botox
n=10 Participants
300 units Botulinum-A toxin
|
Placebo
n=7 Participants
Placebo
|
|---|---|---|---|
|
Episodes/Day
|
6.6 number
Standard Error 0.9687
|
3.52 number
Standard Error 0.95
|
8.7 number
Standard Error 1.52
|
Adverse Events
200 Units Botox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
300 Units Botox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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