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Intravesical OnabotulinumtoxinA During Prolapse Surgery for OAB
NCT04807920Phase 4
Key facts
- Status
- Unknown
- Start
- Sep 2021
- Primary completion
- Jun 2023
- Countries
- 1
- Sponsor
- Walter Reed National Military Medical Center
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- overactive bladder syndrome (OAB)
01
Overview
Phase 4, randomised, double-blind trial in overactive bladder syndrome (OAB) comparing Intravesical OnabotulinumtoxinA with Placebo (2 arms). Primary endpoint: Overactive Bladder Questionnaire Short Form. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Intravesical OnabotulinumtoxinA
100 units of BOTOX injected at 20 sites.
Placebo
Injectable saline injected at 20 sites.
03
Who it enrols
Women scheduled for prolapse surgery with bothersome OAB symptoms (OAB-q SF > 20) willing to perform self-catheterization.
04
Endpoints
Primary
Overactive Bladder Questionnaire Short Form
Secondary
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire Short Form
Patient Global Impression of Severity Scale
Patient Global Impression of Improvement Scale
Urinary tract infection
Urinary retention
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