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Refractory Urge Incontinence and Botox Injections

Urinary Incontinence Clinical Trial

Official title:
Refractory Urge Incontinence and Botox Injections

Clinical Trial Summary

The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.

Clinical Trial Description

Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in centers across the US. Study participants will undergo cystoscopy (telescope look into the bladder) and injection of either Botox A or placebo. If symptoms are not adequately relieved, subjects participants will receive a second injection that is Botox A. Participants are interviewed monthly by study personnel to determine symptoms and health status. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00373789
Study type Interventional
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact
Status Terminated
Phase Phase 3
Start date June 2006
Completion date December 2007
View Details
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