Trial Outcomes & Findings for Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial (NCT NCT05308979)
NCT ID: NCT05308979
Last Updated: 2026-02-25
Results Overview
Participants will be asked to Overactive Bladder Questionnaire Long Form prior to receiving the Botox procedure. The OAB-Q LF symptom severity sub-scale score will be compared prior to procedure and again to score at 3 weeks after procedure. The OAB-q Symptom Severity Score will be computed at baseline and 3 weeks (and 3 months) using the standard scoring algorithm. Minimum value of symptom severity subscale is 8, maximum is 48. A higher score means worse symptoms. A lower score means less symptoms.
COMPLETED
PHASE4
116 participants
change from baseline OAB-Q score to 3 wk post-procedure score
2026-02-25
Participant Flow
Participant milestones
| Measure |
1 Injection Site
100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
10 Injection Sites
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
44
|
45
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
1 Injection Site
n=58 Participants
100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
10 Injection Sites
n=58 Participants
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 10.72 • n=24 Participants
|
68 years
STANDARD_DEVIATION 11.34 • n=20 Participants
|
68 years
STANDARD_DEVIATION 11 • n=40 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=24 Participants
|
58 Participants
n=20 Participants
|
116 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=24 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=24 Participants
|
35 Participants
n=20 Participants
|
73 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
14 Participants
n=24 Participants
|
18 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: change from baseline OAB-Q score to 3 wk post-procedure scoreParticipants will be asked to Overactive Bladder Questionnaire Long Form prior to receiving the Botox procedure. The OAB-Q LF symptom severity sub-scale score will be compared prior to procedure and again to score at 3 weeks after procedure. The OAB-q Symptom Severity Score will be computed at baseline and 3 weeks (and 3 months) using the standard scoring algorithm. Minimum value of symptom severity subscale is 8, maximum is 48. A higher score means worse symptoms. A lower score means less symptoms.
Outcome measures
| Measure |
1 Injection Site
n=58 Participants
100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
10 Injection Sites
n=58 Participants
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
|---|---|---|
|
Change in Overactive Bladder Questionnaire Long Form Score (Symptoms Severity Sub-scale)(OAB-Q LF)
|
-31.2 units on a scale
Standard Deviation 26.25
|
-39.5 units on a scale
Standard Deviation 24.92
|
SECONDARY outcome
Timeframe: comparison of baseline OAB-Q HRQL score to 3 month post-procedure scoreParticipants will be asked to complete Overactive Bladder Questionnaire Long Form prior to receiving the Botox procedure. The OAB-Q LF HRQL sub-scale score will be compared prior to procedure and again to score at 3 months after procedure. The score range for the OAB-Q LF HRQL score is 0-100. An increased score equates to improvement in quality of life. A positive change equates to improvement in quality of life. A negative change equates to decreased quality of life.
Outcome measures
| Measure |
1 Injection Site
n=39 Participants
100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
10 Injection Sites
n=39 Participants
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
|---|---|---|
|
Change in Overactive Bladder Questionnaire Long Form Score (Health Related Quality of Life)(OAB-Q LF HRQL Subscale)
|
31.4 score
Standard Deviation 25.13
|
34.8 score
Standard Deviation 20.64
|
SECONDARY outcome
Timeframe: PVR collected at 3 wk post-procedureA PVR will be collected via either urethral catheterization or bladder scan (ultrasound in clinic) at 3 weeks post-procedure as a marker of urinary retention. The PVRs will be compared between study and control groups
Outcome measures
| Measure |
1 Injection Site
n=58 Participants
100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
10 Injection Sites
n=58 Participants
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
|---|---|---|
|
Post-void Residual (PVR)
|
83.4 mL
Standard Deviation 82.45
|
83.5 mL
Standard Deviation 75.48
|
SECONDARY outcome
Timeframe: anytime after procedure, until at least 3 months post-procedure.Urine culture will be sent for any patient with urinary tract infections symptoms (eg: worsening urgency, frequency, dysuria).
Outcome measures
| Measure |
1 Injection Site
n=58 Participants
100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
10 Injection Sites
n=58 Participants
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
|---|---|---|
|
Number of Participants With Urinary Tract Infection (UTI)
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 months after botox procedurePopulation: Score of 1 very much better
Participants will complete PGI-I Questionnaire at 3 months after procedure. The minimum value is 1 (very much better) and maximum value score is 7 (very much worse). A higher score indicates worse symptoms. A lower score indicates better symptoms or more improvement.
Outcome measures
| Measure |
1 Injection Site
n=40 Participants
100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
10 Injection Sites
n=42 Participants
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
|---|---|---|
|
Number of Patients With Patient Global Impression - Improvement (PGI-I) Score of 1
|
11 participants
|
11 participants
|
SECONDARY outcome
Timeframe: immediately after procedureParticipants will complete VAS-pain immediately post-procedure as a pain and tolerability assessment. Score on a scale of (0-100) with 0 being no pain and 100 being highest level of pain.
Outcome measures
| Measure |
1 Injection Site
n=58 Participants
100u Botox® injected at one intradetrusor site
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
10 Injection Sites
n=58 Participants
100u Botox® injected at 10 intradetrusor sites
OnabotulinumtoxinA 100 UNT \[Botox\]: Intradetrusor (Bladder) Botox Injection at 1 vs 10 injection sites
|
|---|---|---|
|
Visual Analogue Scale (VAS) - Pain
|
25.7 score on a scale
Standard Deviation 27.87
|
31.7 score on a scale
Standard Deviation 26.47
|
Adverse Events
1 Injection Site
10 Injection Sites
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