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

Genital Prolapse Clinical Trial

Official title:
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair: an Observational Post-Market Clinical Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06296316
Study type Observational
Source Coloplast A/S
Contact Martine Dehez
Phone +33 6 34 40 83 40
Email frmdeh@coloplast.com
Status Recruiting
Phase
Start date November 21, 2023
Completion date December 2031
View Details
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