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

NACompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

May 31, 2009

Study Completion Date

November 30, 2009

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

Trial Locations (11)

23502

Norfolk General, Norfolk

28203

CHCS - Carolinas Medical Center, Charlotte

29572

Carolina Urologic Research Center, Myrtle Beach

37203

Centennial Hospital, Nashville

48109

The University of Michigan HS, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

77030

Baylor College of Medicine, Houston

78229

Christus Santa Rosa Hospital, San Antonio

80262

University of Colorado Health, Denver

90067

Century City Docotrs Hospital, Los Angeles

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

Sponsors
All Listed Sponsors
lead

American Medical Systems

INDUSTRY

NCT00904969 - A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence | Biotech Hunter | Biotech Hunter