Trial Outcomes & Findings for Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder (NCT NCT02995967)
NCT ID: NCT02995967
Last Updated: 2019-03-13
Results Overview
The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
TERMINATED
NA
3 participants
12 weeks
2019-03-13
Participant Flow
Although 3 participants completed the study, no analysis done due to study being stopped for poor enrollment.
Participant milestones
| Measure |
Botulinum Toxin A Alone Group
Intradetrusor injection of 100 units of botulinum toxin A alone
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a
|
Hydrodistention Group
Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder
Baseline characteristics by cohort
| Measure |
Botulinum Toxin A Alone Group
n=1 Participants
Intradetrusor injection of 100 units of botulinum toxin A alone
Botulinum toxin-A: Intradetrusor injection of 100 units of botulinum toxin a
|
Hydrodistention Group
n=2 Participants
Hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A
Hydrodistention: The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
age over 50 yrs
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
age uner 50 yrs
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or AlaskaNative
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: No analysis done due to study being stopped for poor enrollment
The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of \> 300 mL or \> 150 mL in the presence of bothersome retention symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: No analysis done due to study being stopped for poor enrollment
Subjective outcome at 24 weeks using the OAB-q
Outcome measures
Outcome data not reported
Adverse Events
Botulinum Toxin A Alone Group
Hydrodistention Group
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