NCT00998790

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-10-20
• Last updated: 2018-10-22
• Results posted: 2018-10-22

Locations

3 sites across 2 countries: Belgium, France