Urinary Incontinence Clinical Trial
Official title:
Evaluation of the Efficacy of Botulinum-A Toxin/DMSO Instillation in the Treatment of Women With Over Active Bladder (OAB) Syndrome and/or Urinary Urge Incontinence
The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.
The primary objective of this study is to evaluate the efficacy of catheter-based
instillation of a solution of Botox/DMSO as a novel method for treating women with
overactive bladder (OAB) and secondary urinary incontinence who have failed oral
pharmacologic therapy. This study will test the broad hypothesis that administration of
Botox/DMSO instillations into the bladder with a urethral catheter can significantly improve
symptoms and quality of life in patients with OAB when compared to DMSO installations alone.
Explicitly, we hypothesize that scores on the validated Incontinence Quality of Life (I-QOL)
questionnaire of women with OAB who receive Botox/DMSO instillation will be much improved at
three-month follow-up compared to similar women receiving DMSO instillation alone. Our
long-term goal is to offer women with detrusor hyperreflexia or OAB a less invasive
alternative to surgery and an alternative to anticholinergic by mouth medications. In
support of this effort, we are proposing a randomized, double-blind, placebo controlled
clinical trial to be conducted in the Department of Urology at Mayo Clinic, Jacksonville,
Florida.
Note: The study was terminated early in July of 2011 due to an extended medical absence of
the Principal Investigator.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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