Using Restorelle Mesh for Repairing Apical Prolapse
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair: an Observational Post-Market Clinical Study
This study is looking at how well Restorelle mesh works for women having surgery to fix apical prolapse and how it affects their recovery over the next 5 to 8 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 428 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Coloplast A/S Industry-sponsored |
| Locations | 10 sites (Avranches, Choisir Une Région and 9 other locations) |
| Trial ID | NCT06296316 on ClinicalTrials.gov |
What this trial studies
This observational study aims to follow women who undergo sacrocolpopexy using Restorelle® mesh for apical prolapse repair. It will assess the safety and clinical benefits of the mesh over a period of 5 to 8 years post-surgery. Patients will be monitored through routine care and Patient Reported Outcomes (PRO) to gather comprehensive data on their recovery and mesh performance. The study is designed to provide insights into the long-term effectiveness of this treatment option.
Who should consider this trial
Good fit: Ideal candidates for this study are adult women aged 18 and older who are eligible for surgical treatment of apical pelvic organ prolapse.
Not a fit: Patients who are currently pregnant, breastfeeding, or under legal protection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the long-term safety and effectiveness of Restorelle mesh for women suffering from apical prolapse.
How similar studies have performed: Other studies have shown promising results with similar mesh approaches for pelvic organ prolapse, indicating a potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Avranches, Choisir Une Région and 9 other locations
- Polyclinique de la Baie — Avranches, Choisir Une Région, France (Not_yet_recruiting)
- Centre Aliénor d'Aquitaine — Bordeaux, France (Not_yet_recruiting)
- CHU Pellegrin — Bordeaux, France (Not_yet_recruiting)
- CH Paul Ardier d'Issoire — Issoire, France (Not_yet_recruiting)
- CH La Rochelle — La Rochelle, France (Recruiting)
- Clinique Bon Secours — Le Puy-en-Velay, France (Recruiting)
- CH Général Robert Boulin — Libourne, France (Not_yet_recruiting)
- Institut Mutualiste Montsouris — Paris, France (Not_yet_recruiting)
- CH privé Saint Grégoire — Saint-Grégoire, France (Not_yet_recruiting)
- CH de Saintonge — Saintes, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Philippe Ferry, Dr — CH La Rochelle, France
- Study coordinator: Martine Dehez
- Email: frmdeh@coloplast.com
- Phone: +33 6 34 40 83 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.