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A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence — AMS051  

Urinary Incontinence, Stress Clinical Trial

Official title:
A Pre-Market Study of the AMS Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence

Clinical Trial Summary

The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication.

Clinical Trial Description

A multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionnaire). Intra-operative procedural data will be collected.

Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) will be used to characterize continence status.

Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00904969
Study type Interventional
Source American Medical Systems
Contact
Status Completed
Phase N/A
Start date September 2005
Completion date November 2009
View Details
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