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

NCT06296316 | Terminated

• 1 other identifier: IU022
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Genital Prolapse

Keywords

Apical prolapse; Transabdominal mesh; Pelvic organ prolapse; Sacrocolpopexy; Sacrocervicopexy; Sacrohysteropexy

Outcome Measures

Primary Outcomes (1)

• The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up

  up to 5 years

Secondary Outcomes (24)

• Incidence rate of surgical reintervention related to Restorelle mesh use in patients

  through study completion, at least 5 and up to 8 years

• Number of patients who have only had surgical reintervention not related to Restorelle mesh use

  through study completion, at least 5 and up to 8 years

• Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use

  through study completion, at least 5 and up to 8 years

• Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use)

  5 years ; up to 8-year after index procedure

• Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use)

  5 years ; up to 8-year after index procedure

Interventions

Restorelle Polypropylene Mesh DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult female patients presenting with apical pelvic organ prolapse which is clinically indicated for a surgical treatment with Restorelle mesh

You may qualify if:

• Female patient of at least 18 years old
• Patient presenting apical pelvic organ prolapse and being eligible to surgical treatment
• Patient having received appropriate information and counselling before mesh implantation
• Patient has been provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead
• International Clinical Trials Association: collaborator

Study Sites (6)

Polyclinique de la Baie

Avranches, Choisir Une Région, 50300, France

Location

CHU Pellegrin

Bordeaux, 33076, France

Location

CH La Rochelle

La Rochelle, 17019, France

Location

Clinique Bon Secours

Le Puy-en-Velay, 43000, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

CH de Saintonge

Saintes, 17108, France

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Ferry, Dr

  CH La Rochelle, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: March 6, 2024
• Study Start: November 21, 2023
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)