A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence

NACompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Stress Urinary Incontinence
Interventions
DEVICE

American Medical Systems (AMS) AdVance™ Male Sling System

The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male 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.

Trial Locations (3)

44314

Clinique Jules Verne, Nantes

69435

Hopital Edouard Herriot, Lyon

Unknown

Universitaire Ziekenhuisen Leuven, Leuven

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY