NCT04807920

BOTOX® at the Time of Prolapse Surgery for OAB

Intravesical OnabotulinumtoxinA Injection at the Time of Prolapse Surgery for the Treatment of Overactive Bladder Syndrome: a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study will be to assess the efficacy and safety of bladder BOTOX® for overactive bladder symptoms, such as urinary urgency and frequency, given at the time of prolapse surgery.

Detailed description

After being informed about the study and the potential risks, women scheduled for prolapse surgery will be screened for bothersome overactive bladder symptoms. Those that qualify and choose to enroll will be randomized to receive either bladder BOTOX® or a placebo at the time of their surgery. Neither the patient nor the investigators will know if the patient receives BOTOX® or a placebo. Subjects will complete questionnaires and bladder diaries both before and after surgery to determine efficacy and patient satisfaction. Potential adverse events, such as urinary tract infections and urinary retention, will be monitored throughout the study.

Conditions

• Urinary Bladder, Overactive
• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA 100 UNT	Intravesical injection
OTHER	Injectable saline	Intravesical injection

Timeline

• Start date: 2021-09-23
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2021-03-19
• Last updated: 2021-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study