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Recruiting NCT04098822

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

— Observational Urinary Incontinence, Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtue male sling.
Who it may be relevant to
Registry conditions: Urinary Incontinence, Stress. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort in Subjects With Male Stress Urinary Incontinence

Overview

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.

Detailed 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.

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.

Primary outcome measures

  • Patient Global Impression of Improvement (PGI-I) [Time frame: 12 months]
  • Adverse events [Time frame: 12 months]
Secondary outcome measures (7)
  • Pad weight testing [Time frame: Baseline, 8 weeks and 12 months]
  • Uroflowmetry [Time frame: Baseline, 8 weeks, 12 months]
  • Post-void residual (PVR) volume [Time frame: Baseline, 8 weeks, 12 months]
  • Pad Use [Time frame: Baseline, 8 weeks, 12, 24, 36 months]
  • International Consultation on Incontinence Questionnaire (ICIQ-UI) [Time frame: Baseline, 8 weeks, 12, 24, 36 months]
  • Subject global satisfaction questionnaire [Time frame: 8 weeks, 12, 24, 36 months]
  • Incontinence quality of life questionnaire (I-QoL) [Time frame: Baseline, 8 weeks, 12, 24, 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 12 centers
  • CHU Angers — Angers
  • Jean Minjoz Hospital — Besançon
  • CHU de Caen — Caen
  • Centre Hospitalier Chalon Sur Saône William Morey — Chalon-sur-Saône
  • Groupe Hospitalier Henri Mendor — Créteil
  • Claude Huriez Hospital — Lille
  • Clinique Mutualiste de la Porte de l'Orient — Lorient
  • Edouard Herriot Hospital — Lyon
  • … and 4 more centers
Italy · 1 center
  • Ospedale Generale Regionale F. Miull — Acquaviva delle Fonti

Identifiers

NCT: NCT04098822 · SU018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗