Botox for the Treatment of Overactive Bladder Secondary to Benign Prostatic Obstruction

Overactive Bladder Clinical Trial

Official title: Randomized Double-blind Placebo Controlled Trial of Intradetrusor Injections of Botox for the Treatment of Refractory Overactive Bladder Secondary to Benign Prostatic Obstruction-BTX0621

Status Completed

Clinical Trial Summary

This is a prospective, randomized, double-blind study comparing intravesical injection of BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following treatment groups:

Clinical Trial Description

Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0), subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and 270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.

Subjects demonstrating an insufficient response to treatment may receive an open-label injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will re-commence Follow-up Visits and be followed for an additional 270 days. ;

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

• NCT number: NCT01220726
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Status: Completed
• Phase: Phase 3
• Start date: June 2009
• Completion date: November 13, 2012