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A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence

NCT04098822 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2023-02-21

No results posted yet for this study

Summary

The purpose of this study is to monitor the use of Virtue® Male Sling in a real world population and collect medical data on effectiveness and to monitor safety of Virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.

Conditions

  • Urinary Incontinence, Stress

Interventions

DEVICE

Virtue male sling

The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from in-trinsic sphincter deficiency (ISD). The sling is manufactured from polypropylene and is sold for single use only. The device is a quadratic sling and consists of a knitted monofilament polypropylene mesh. The body of the device provides surface area for supporting the bulbous urethra.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • René Yiou, Pr · CHU Henri Mondor, Créteil, France

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • France
  • Italy

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 NCT04098822 on ClinicalTrials.gov