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Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

Urinary Incontinence, Stress Clinical Trial

Official title:
A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence

Clinical Trial Summary

This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).

Clinical Trial Description

Study comparing intrasphincteric injection of AMDC-USR with placebo. Subjects unblinded after 12 months visits, but followed for 2 years. Subjects randomized to placebo could elect to receive open-label AMDC-USR after completing 12 months visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01382602
Study type Interventional
Source Cook MyoSite
Contact
Status Completed
Phase Phase 3
Start date November 4, 2011
Completion date January 29, 2017
View Details
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