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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


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

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