Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT04807920
Brief 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.
Study:
NCT04807920
Study Brief:
Protocol Section:
NCT04807920