Stress Urinary Incontinence Clinical Trial
Official title:
A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. 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. This study is not designed to statistically demonstrate safety and efficacy of the device.
A prospective, 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 Questionaire). Intra-operative procedural data will be
collected.
Pad weight and incontinence severity rating (using the ICIQ survey) 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.
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