NCT06296316

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Genital Prolapse

Interventions

Type	Name	Description
DEVICE	Restorelle Polypropylene Mesh	The Coloplast Restorelle® Polypropylene Mesh is a Class III, implantable, permanent, non-absorbable, single use device indicated to restore female pelvic floor anatomy by providing anatomical support and suspension as a bridging material to support deficient fascia that resulted in descent of the female pelvic organs (pelvic organ prolapse). Restorelle mesh is a synthetic, macroporous mesh constructed of medical grade knitted, monofilament polypropylene.

Timeline

• Start date: 2023-11-21
• Primary completion: 2024-11-06
• Completion: 2024-11-06
• First posted: 2024-03-06
• Last updated: 2026-01-28

Locations

6 sites across 1 country: France