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

NCT00998790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2018-10-22

Study results available
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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.

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Armin Becker, MD · Oberarzt der Urologischen Klinik Grosshadern

  • Dirk de Ridder, Professor · UZ Gasthuisberg

  • Pedro Arano, MD · Fundacion Puigvert

  • Francois Haab, Professor · Institution Tenon Hospital

  • Olivier Haillot, Professor · Hopital Bretonneau

  • Philippe Chauveau, MD · Clinique Jules Verne

  • Hakim Fassi-Fehri, MD · Hopital Edouard Herriot

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00998790 on ClinicalTrials.gov