Trial Outcomes & Findings for A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence (NCT NCT00345332)
NCT ID: NCT00345332
Last Updated: 2017-07-11
Results Overview
The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
week 13
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Placebo Group
6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
|
Botox Group
Botox (BTX) was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
20
|
|
Overall Study
COMPLETED
|
11
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Placebo Group
n=11 Participants
6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
|
Botox Group
n=20 Participants
BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.45 years
STANDARD_DEVIATION 12.85 • n=99 Participants
|
65.15 years
STANDARD_DEVIATION 10.83 • n=107 Participants
|
65.97 years
STANDARD_DEVIATION 11.55 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
20 participants
n=107 Participants
|
31 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: week 13The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.
Outcome measures
| Measure |
Placebo Group
n=11 Participants
6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
|
Botox Group
n=20 Participants
BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
|
|---|---|---|
|
Incontinent Episodes Per Day
|
7.34 incontinence episodes per day
Standard Error 1.07
|
3.90 incontinence episodes per day
Standard Error 0.75
|
SECONDARY outcome
Timeframe: week 13The number of incontinence pads used per day per day was recorded by each participant in a diary.
Outcome measures
| Measure |
Placebo Group
n=11 Participants
6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
|
Botox Group
n=20 Participants
BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
|
|---|---|---|
|
Number of Incontinence Pads Used Per Day
|
5.18 pads per day
Standard Error 0.92
|
3.13 pads per day
Standard Error 0.66
|
Adverse Events
Placebo Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Botox Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Group
n=11 participants at risk
6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.
|
Botox Group
n=20 participants at risk
BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.
|
|---|---|---|
|
Infections and infestations
urinary tract infection
|
27.3%
3/11
|
55.0%
11/20
|
|
Renal and urinary disorders
post void retention volumes > 200cc
|
0.00%
0/11
|
25.0%
5/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place