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Virtue® Male Sling Fixation Study

NCT01170728 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2015-08-24

No results posted yet for this study

Summary

This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

Coloplast Virtue® Male Sling

The Virtue Male sling is a class II single use implantable sub-urethral, permanent, non-absorbable, support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Craig Comiter, MD · Stanford University

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

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 NCT01170728 on ClinicalTrials.gov