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

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.

Conditions

• Urinary Incontinence, Stress

Interventions

DEVICE

The AMS Male Transobturator Sling System

The AMS Male Transobturator Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD) secondary to radical prostatectomy. The Male Transobturator Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.

DEVICE

AdVance Male Sling

A transobturator sling for the treatment of post-prostatectomy incontinence

Sponsors & Collaborators

• American Medical Systems

  lead INDUSTRY

Principal Investigators

• Gregory Bales, M.D. · University of Chicago Hospital

• Timothy Boone, M.D. · Baylor College of Medicine

• Karyn Eilber, M.D. · Century City Doctors Hospital

• Brian J. Flynn, M.D. · University of Colorado Health

• Michael Guralnick, M.D. · Medical College of Wisconsin

• Sender Herschorn, M.D. · Sunnybrook Health Sciences Centre

• LeRoy Jones, M.D. · CHRISTUS Health

• Gerald Jordan, M.D. · Norfolk General

• Michael Kennelly, M.D. · CHCS - Carolinas Medical Center

• Dean L. Knoll, M.D. · Centennial Hospital

• Edward McGuire, M.D. · The University of Michigan HS

• Brian Roberts, M.D. · Carolina Urologic Research Center

• George D. Webster, M.D. · Duke University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-09-30

Primary Completion

2009-05-31

Completion

2009-11-30

Countries

• United States
• Canada

Study Locations