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

Coloplast

Status: Enrolling

Conditions: Urinary Incontinence, Stress

Treatments: Device: Virtue male sling

Study type: Observational

Funder types: Industry

Identifiers

NCT04098822

SU018

Details and patient eligibility

About

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.

Full description

This project will be launched after the first introduction of Virtue® Male Sling in Europe. This study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with Virtue® Male Sling System by urologists who are experienced in the device. The patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). Routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. Then questionnaires will be mailed annually during 2 additional years.

Enrollment: 130 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implanted with the Virtue® Male Sling System

Exclusion criteria

• Refuses to be included in the survey or that their medical data will be used for research purposes.
• Indication for the Virtue® Male Sling System implantation is not for the treatment of male urinary incontinence