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Sponsors and Collaborators: |
University of Rochester National Institutes of Health (NIH) |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00178191 |
The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.
Condition | Intervention |
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Urinary Incontinence |
Drug: Botulinum A toxin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Botox for Severe Urge Incontinence |
Enrollment: | 28 |
Study Start Date: | June 2005 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
The prevalence of urinary incontinence in the US ranges from 3-14% with epidemiologic estimates ranging widely.1 Most urinary incontinence can be categorized into stress urinary incontinence (SUI) or UUI with UUI remaining more common and debilitating than SUI.2 A major cause of UUI is overactive bladder or detrusor instability (DI), and while DI is very common, its etiology remains unknown. DI is often successfully managed with behavioral therapy, physical therapy, medications and surgery with the most effective therapy being anticholinergic medication.2 However, side effects including dry mouth, and constipation often lead to discontinuation of these drugs. In addition, many patients fail anticholinergic medication and have persistent urinary leakage. Women who fail these treatments have limited options.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: Subjects must have ALL of the following:
Exclusion Criteria:
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 |
Principal Investigator: | Michael K Flynn, MD | University of Rochester |
Responsible Party: | University of Rochester ( Michael K. Flynn, MD ) |
Study ID Numbers: | 10466 |
Study First Received: | September 12, 2005 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00178191 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Botulinum Toxins Urologic Diseases Urination Disorders |
Urinary Incontinence Botulinum Toxin Type A Urinary Incontinence, Urge |
Urological Manifestations Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions |