Trial Outcomes & Findings for Procedural Discomfort Related to Number of Intradetrusor Botox Injections (NCT NCT05652036)
NCT ID: NCT05652036
Last Updated: 2025-04-13
Results Overview
Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups.
COMPLETED
PHASE4
108 participants
Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)
2025-04-13
Participant Flow
Participant milestones
| Measure |
5 mL Group
100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.
|
10 mL Group
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
56
|
|
Overall Study
COMPLETED
|
52
|
56
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Procedural Discomfort Related to Number of Intradetrusor Botox Injections
Baseline characteristics by cohort
| Measure |
5 mL Group
n=52 Participants
100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.
|
10 mL Group
n=56 Participants
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 Years
STANDARD_DEVIATION 14.3 • n=99 Participants
|
70.6 Years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
67.6 Years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Medical Co-Morbidities
Diabetes
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Medical Co-Morbidities
Depression
|
23 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Medical Co-Morbidities
Neurologic Diagnosis
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Medical Co-Morbidities
Recurrent Urinary Tract Infection
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Surgical History
Hysterectomy
|
23 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Surgical History
Prolapse Repair
|
16 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Surgical History
Incontinence Procedure
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
First Botox Injection
Yes
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
First Botox Injection
No
|
30 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups.
Outcome measures
| Measure |
5 mL Group
n=52 Participants
100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.
|
10 mL Group
n=56 Participants
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
|---|---|---|
|
Participant Discomfort Related to BTX-A Injection
|
3.2 score on a scale
Standard Deviation 2.3
|
3.6 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Prior to BTX-A injections and 30 days post-procedurePopulation: Follow-up data 30-days post-treatment was obtained from 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
Efficacy will be evaluated using the Overactive Bladder Questionnaire Short-Form (OAB-q SF), a validated instrument designed to measure symptom bother (SB) and the impact of OAB on health-related quality of life (HRQL). This questionnaire is administered on the day of the procedure (baseline) and again 30 days post-procedure. Changes in SB and HRQL scores assess improvement in OAB symptoms following BTX-A treatment. The OAB-q SF includes 19 items divided into two subscales: a 6-item SB scale (Questions 1-6) and a 13-item HRQL scale (Questions 7-19). SB items are scored from 1 ("not at all") to 6 ("a very great deal"), yielding a total SB score range of 6 to 36, with higher scores indicating greater symptom bother. HRQL items are scored from 1 ("none of the time") to 6 ("all of the time"), with total scores ranging from 13 to 78, where higher scores reflect better quality of life. We report here the mean change in SB and HRQL scores from baseline to 30 days post-treatment.
Outcome measures
| Measure |
5 mL Group
n=36 Participants
100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.
|
10 mL Group
n=43 Participants
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
|---|---|---|
|
Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF)
OAB-q SF (SB (mean difference))
|
-22.4 Units on a scale
Interval -93.0 to 73.0
|
-38.1 Units on a scale
Interval -100.0 to 60.0
|
|
Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF)
OAB-q SF (HRQL (mean difference))
|
14.59 Units on a scale
Interval -59.0 to 60.0
|
26.24 Units on a scale
Interval -30.0 to 71.0
|
SECONDARY outcome
Timeframe: 30 days post-procedurePopulation: Thirty-day follow-up data were available for 69% (n = 36) in the 5 mL/5 injection arm and 77% (n = 43) in the 10 mL/10 injection arm.
Overall treatment satisfaction will be assessed at 30-days post-procedure via a "yes or no" response to inquiry about overall satisfaction with the procedure and results of their BTX-A treatment
Outcome measures
| Measure |
5 mL Group
n=36 Participants
100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.
|
10 mL Group
n=43 Participants
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
|---|---|---|
|
Overall Treatment Satisfaction
Satisfied
|
33 Participants
|
34 Participants
|
|
Overall Treatment Satisfaction
Not Satisfied
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 days post-procedurePopulation: Thirty-day follow-up data were available for 69% (n = 36) in the 5 mL/5 injection arm and 77% (n = 43) in the 10 mL/10 injection arm.
Patients impression of clinical improvement after treatment will be assessed at 30-day post-procedure via the Clinical Global Impression - Improvement Scale (CGI-I). The CGI-I is a seven point verbal scale with higher values indicating higher impression of symptomatic improvement related to the treatment. Scale reports values as: Very much improved, Much improved, Minimally improved, No difference.
Outcome measures
| Measure |
5 mL Group
n=36 Participants
100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.
|
10 mL Group
n=43 Participants
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
|---|---|---|
|
Impression of Clinical Improvement
Very much improved
|
9 Participants
|
9 Participants
|
|
Impression of Clinical Improvement
Much improved
|
18 Participants
|
16 Participants
|
|
Impression of Clinical Improvement
Minimally improved
|
7 Participants
|
15 Participants
|
|
Impression of Clinical Improvement
No difference
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 days post-procedurePopulation: Post-procedural Adverse Outcomes - Urinary retention, Urinary tract infection, Bleeding requiring evaluation, Hematuria, Bladder pain, and Emergency department evaluation. n=36 and n=43 participants were evaluated for the 5ml and 10ml arms respectively.
We will review the electronic medical record to evaluate instances of symptomatic urinary tract infection, bothersome incomplete bladder emptying requiring catheterization, and instances of bleeding requiring evaluation after the procedure.
Outcome measures
| Measure |
5 mL Group
n=36 Participants
100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.
|
10 mL Group
n=43 Participants
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
|---|---|---|
|
Procedural Outcomes
Urinary retention
|
0 Participants
|
2 Participants
|
|
Procedural Outcomes
Urinary tract infection
|
5 Participants
|
2 Participants
|
|
Procedural Outcomes
Bleeding requiring evaluation
|
0 Participants
|
0 Participants
|
|
Procedural Outcomes
Hematuria
|
1 Participants
|
0 Participants
|
|
Procedural Outcomes
Bladder pain
|
0 Participants
|
1 Participants
|
|
Procedural Outcomes
Emergency department evaluation
|
0 Participants
|
2 Participants
|
Adverse Events
5 mL Group
10 mL Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
5 mL Group
n=36 participants at risk
100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.
|
10 mL Group
n=43 participants at risk
100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
13.9%
5/36 • Number of events 5 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
4.7%
2/43 • Number of events 2 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/36 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
4.7%
2/43 • Number of events 2 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
|
Renal and urinary disorders
Bleeding Requiring Evaluation
|
0.00%
0/36 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
0.00%
0/43 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
|
Renal and urinary disorders
Hematuria
|
2.8%
1/36 • Number of events 1 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
0.00%
0/43 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
|
Renal and urinary disorders
Bladder Pain
|
0.00%
0/36 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
2.3%
1/43 • Number of events 1 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
|
Renal and urinary disorders
Emergency Department Evaluation
|
0.00%
0/36 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
4.7%
2/43 • Number of events 2 • 1 month post-treatment
Thirty-day AE data were available for 69% (n = 36) of participants in the 5 mL/5 injection arm and 77% (n = 43) of participants in the 10 mL/10 injection arm.
|
Additional Information
Dr. Rose Khavari
Houston Methodist Hospital Department of Urology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place