Viewing Study NCT00178191



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Last Modification Date: 2024-10-26 @ 9:16 AM
Study NCT ID: NCT00178191
Status: COMPLETED
Last Update Posted: 2011-10-03
First Post: 2005-09-12

Brief Title: Randomized Trial for Botox Urinary Incontinence
Sponsor: University of Rochester
Organization: University of Rochester

Study Overview

Official Title: A Randomized Trial of Botox for Severe Urge Incontinence
Status: COMPLETED
Status Verified Date: 2011-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: The prevalence of urinary incontinence in the US ranges from 3-14 with epidemiologic estimates ranging widely1 Most urinary incontinence can be categorized into stress urinary incontinence SUI or UUI with UUI remaining more common and debilitating than SUI2 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 medication2 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R21AG025490-01 NIH None httpsreporternihgovquickSearch1R21AG025490-01