Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair

Last updated: February 28, 2024
Sponsor: Coloplast A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Restorelle Polypropylene Mesh

Clinical Study ID

NCT06296316
IU022
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patient of at least 18 years old
  • Patient presenting apical pelvic organ prolapse and being eligible to surgicaltreatment
  • Surgeon having decided to treat the patient with a Restorelle mesh as per its CE markindication and IFU, before patient inclusion
  • Patient having received appropriate information and counselling before meshimplantation
  • Patient has been provided written informed consent

Exclusion

Exclusion Criteria:

  • Patient currently pregnant or breastfeeding
  • Patient being deprived of liberty by a judicial or administrative decision, or who isunder a measure of legal protection

Study Design

Total Participants: 428
Treatment Group(s): 1
Primary Treatment: Restorelle Polypropylene Mesh
Phase:
Study Start date:
November 21, 2023
Estimated Completion Date:
December 31, 2031

Study Description

This study is a non-interventional, multicenter and post market clinical follow-up in adult women with apical prolapse under normal conditions of use (after a sacrocolpopexy with Restorelle mesh for apical prolapse repair as part of routine care). The patient will be followed for 1 year (or less) by the investigator as per local usual practice. At the same time, the patient will be followed via PRO (Patient Reported Outcomes) over a period of 5 to 8 years.

Connect with a study center

  • Polyclinique de la Baie

    Avranches, Choisir Une Région 50300
    France

    Site Not Available

  • CHU Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • Centre Aliénor d'Aquitaine

    Bordeaux, 33076
    France

    Site Not Available

  • CH Paul Ardier d'Issoire

    Issoire, 63500
    France

    Site Not Available

  • CH La Rochelle

    La Rochelle, 17019
    France

    Active - Recruiting

  • Clinique Bon Secours

    Le Puy-en-Velay, 43000
    France

    Active - Recruiting

  • CH Général Robert Boulin

    Libourne, 33505
    France

    Site Not Available

  • Institut Mutualiste Montsouris

    Paris, 75014
    France

    Site Not Available

  • CH privé Saint Grégoire

    Saint-Grégoire, 35760
    France

    Site Not Available

  • CH de Saintonge

    Saintes, 17108
    France

    Site Not Available

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