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

NCT04098822 | Recruiting

• 1 other identifier: SU018
• Study Type: observational
• Target: 130
• Locations: 2 countries
• Sites: 13

Brief 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

Keywords

Urinary Incontinence, Stress; Suburethral Slings; Prostatectomy

Outcome Measures

Primary Outcomes (2)

• Patient Global Impression of Improvement (PGI-I)

  PGI-I is a validated questionnaire that collects the patient's impression of improvement after the surgery. Among this 7-point scale (very much better, much better, a little better, no change, a little worse, much worse and very much worse), we ask the patients to check the one number that best decribes how their urinary tract condition is now, compared with how it's was before the surgery. Patients who score little or much or very much better will be considered a treatment success. We measure the percentage of patient who describe the treatment success

  12 months

• Adverse events

  Adverse events are any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects. Adverse events will be categorized according to relatedness to device or procedure, severity, and frequency. At 12-months, we measure the percentage of patients without any device related severe or serious adverse events.

  12 months

Secondary Outcomes (7)

• Pad weight testing

  Baseline, 8 weeks and 12 months

• Uroflowmetry

  Baseline, 8 weeks, 12 months

• Post-void residual (PVR) volume

  Baseline, 8 weeks, 12 months

• Pad Use

  Baseline, 8 weeks, 12, 24, 36 months

• International Consultation on Incontinence Questionnaire (ICIQ-UI)

  Baseline, 8 weeks, 12, 24, 36 months

Interventions

Virtue male sling DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient implanted with Virtue® Male Sling System to treat post-prostatectomy urinary incontience

You may qualify if:

• Implanted with the Virtue® Male Sling System

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (13)

CHU Angers

Angers, 49933, France

RECRUITING

Jean Minjoz Hospital

Besançon, 25030, France

RECRUITING

CHU de Caen

Caen, 14033, France

RECRUITING

Centre Hospitalier Chalon Sur Saône William Morey

Chalon-sur-Saône, 71321, France

RECRUITING

Groupe Hospitalier Henri Mendor

Créteil, 94010, France

TERMINATED

Claude Huriez Hospital

Lille, 59037, France

WITHDRAWN

Clinique Mutualiste de la Porte de l'Orient

Lorient, 56100, France

COMPLETED

Edouard Herriot Hospital

Lyon, 69003, France

COMPLETED

Clinique de l'Esperance

Mougins, 06250, France

COMPLETED

CHU Carémeau

Nîmes, 30029, France

RECRUITING

Clinique Urologique Nantes-Atlantis

Saint-Herblain, 44800, France

RECRUITING

Clinique Paul Picquet

Sens, 89000, France

WITHDRAWN

Ospedale Generale Regionale F. Miull

Acquaviva delle Fonti, 70021, Italy

WITHDRAWN

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• René Yiou, Pr

  CHU Henri Mondor, Créteil, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Ryckebusch, Dr

CONTACT

+33 1 40 83 68 52; frhr@coloplast.com

Martine Dehez

CONTACT

+33 9 83 54 12 45; frmdeh@coloplast.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: September 23, 2019
• Study Start: June 29, 2017
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12); IT (1)