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

Coloplast

Status: Enrolling

Conditions: Genital Prolapse

Treatments: Device: Restorelle Polypropylene Mesh

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06296316

IU022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 428 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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