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

NCT ID: NCT04098822

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-29

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Incontinence, Stress

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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René Yiou, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Henri Mondor, Créteil, France

Locations

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CHU Angers

Angers, , France

Site Status RECRUITING

Jean Minjoz Hospital

Besançon, , France

Site Status RECRUITING

CHU de Caen

Caen, , France

Site Status RECRUITING

Centre Hospitalier Chalon Sur Saône William Morey

Chalon-sur-Saône, , France

Site Status RECRUITING

Groupe Hospitalier Henri Mendor

Créteil, , France

Site Status TERMINATED

Claude Huriez Hospital

Lille, , France

Site Status WITHDRAWN

Clinique Mutualiste de la Porte de l'Orient

Lorient, , France

Site Status COMPLETED

Edouard Herriot Hospital

Lyon, , France

Site Status COMPLETED

Clinique de l'Esperance

Mougins, , France

Site Status COMPLETED

CHU Carémeau

Nîmes, , France

Site Status RECRUITING

Clinique Urologique Nantes-Atlantis

Saint-Herblain, , France

Site Status RECRUITING

Clinique Paul Picquet

Sens, , France

Site Status WITHDRAWN

Ospedale Generale Regionale F. Miull

Acquaviva delle Fonti, , Italy

Site Status WITHDRAWN

Countries

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France Italy

Central Contacts

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Hugo Ryckebusch, Dr

Role: CONTACT

[email protected]
+33 1 40 83 68 52

Martine Dehez

Role: CONTACT

[email protected]
+33 9 83 54 12 45

Facility Contacts

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Thibaut Culty, Dr

Role: primary

François Kleinclauss, Pr

Role: primary

Xavier Tillou, Pr

Role: primary

Nicolas Koutlidis, Dr

Role: primary

Laurent Wagner, Dr

Role: primary

Thierry Rousseau, Dr

Role: primary

Other Identifiers

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SU018

Identifier Type: -

Identifier Source: org_study_id

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