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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Urological Sciences Research Foundation
Updated on 7 November 2020
botox
anticholinergic agents
indwelling catheter
intravesical injections
intermittent catheterization

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).

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.

Details
Condition Overactive Bladder
Treatment Botox
Clinical Study IdentifierNCT00479596
SponsorUrological Sciences Research Foundation
Last Modified on7 November 2020

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