BOTOX® at the Time of Prolapse Surgery for OAB

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04807920
Study type	Interventional
Source	Walter Reed National Military Medical Center
Contact	Joy E Wheat, MD
Phone	201-710-5109
Email	joy.e.wheat.mil@mail.mil
Status	Recruiting
Phase	Phase 4
Start date	September 23, 2021
Completion date	June 2023

View Details

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