OnabotulinumtoxinA 100 UNT for Overactive Bladder

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Overactive Bladder+1 MoreOnabotulinumtoxinA 100 UNT - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will study whether BOTOX can help treat overactive bladder symptoms during prolapse surgery.

Eligible Conditions
  • Overactive Bladder
  • Pelvic Organ Prolapse

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: At 6-12 weeks postoperatively

At 6-12 weeks postoperatively
Patient Global Impression of Improvement Scale (PGI-I) at 6 to 12 weeks postoperatively.
Week 12
Urinary retention
Week 12
Change from baseline to postoperative weeks 6 to 12 in Overactive Bladder bother short form (OAB-q SF) questionnaire looking for a decrease of 10 points, which is the minimally important difference.
Change from baseline to postoperative weeks 6 to 12 in Patient Global Impression of Severity Scale (PGI-S).
Change from baseline to postoperative weeks 6 to 12 in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12).
Week 12
Urinary tract infection

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Intravesical OnabotulinumtoxinA
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

138 Total Participants · 2 Treatment Groups

Primary Treatment: OnabotulinumtoxinA 100 UNT · Has Placebo Group · Phase 4

Intravesical OnabotulinumtoxinA
Drug
Experimental Group · 1 Intervention: OnabotulinumtoxinA 100 UNT · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Injectable saline · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 6-12 weeks postoperatively

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
125 Previous Clinical Trials
35,890 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a woman scheduled for prolapse surgery.
You have bothersome OAB symptoms.
You are willing to perform clean intermittent catheterization (CIC).
References