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This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo. — BTX0621  

Overactive Bladder Clinical Trial

Official title:
Safety and Efficacy Study of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction (BTX0621)

Clinical Trial Summary

The current study will investigate the comparative efficacy, safety and patient satisfaction of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in the treatment of OAB secondary to benign prostatic obstruction (BPO).

Clinical Trial Description

Overactive bladder is a common problem that follows chronic prostatic bladder outlet obstruction and is part of the benign prostatic hyperplasia syndrome (BPH) in men. Unfortunately, it does not often resolve after treatment (TURP, etc) of the obstruction from enlarged prostate gland. Patients with obstructive BPH typically commence treatment with alpha-blockers or anticholinergic agents; the former being used to treat enlarged prostate medically, and the latter to treat overactive bladder symptoms. However, as mentioned, anticholinergics cause many intolerable side effects leading to discontinuation in many patients. Furthermore this class of drug is still considered a relative contraindication in this population by some clinicians. Therefore other modalities need to be studied in these men.

Based on numerous studies in overactive bladder (OAB), we hypothesize that these patients will experience significant improvement (particularly if their symptoms of urgency and frequency) without significant side effects from intradetrusor injections of BOTOX® even though they have were refractory to systemic anticholinergics. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00479596
Study type Interventional
Source Urological Sciences Research Foundation
Contact Leonard S Marks, M.D.
Phone (310) 838-6347
Email lsmarks@ucla.edu
Status Recruiting
Phase Phase 2/Phase 3
Start date January 2007
Completion date May 2007
View Details
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