Trial Outcomes & Findings for Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial (NCT NCT05308979)

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

116 participants

Primary outcome timeframe

change from baseline OAB-Q score to 3 wk post-procedure score

Results posted on

2025-02-28

Participant Flow

Participant milestones

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

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=5 Participants	68 years STANDARD_DEVIATION 11.34 • n=7 Participants	68 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: change from baseline OAB-Q score to 3 wk post-procedure score

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.

Outcome measures

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 score to 3 month post-procedure score

Participants will be asked to complete 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 months 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

Outcome data not reported

SECONDARY outcome

Timeframe: PVR collected at 3 wk post-procedure

A 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

Outcome data not reported

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

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months after botox procedure

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

Outcome data not reported

SECONDARY outcome

Timeframe: immediately after procedure

Participants will complete VAS-pain immediately post-procedure as a pain and tolerability assessment

Outcome measures

Outcome data not reported

Adverse Events

1 Injection Site

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

10 Injection Sites

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

Dr. Carly Crowder

UC Irvine Medical Center

Phone: 7144562911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place