Clinical trial NCT06296316: Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair
Official title: Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair: an Observational Post-Market Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genital Prolapse
Keywords: Apical prolapse
Transabdominal mesh
Pelvic organ prolapse
Sacrocolpopexy
Sacrocervicopexy
Sacrohysteropexy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
Collaborators: name: International Clinical Trials Association
First posted: 2024-03-06
Enrollment: 428
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: up to 5 years
Secondary outcomes:
measure: Incidence rate of surgical reintervention related to Restorelle mesh use in patients
timeFrame: through study completion, at least 5 and up to 8 years
measure: Number of patients who have only had surgical reintervention not related to Restorelle mesh use
timeFrame: through study completion, at least 5 and up to 8 years
measure: Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use
timeFrame: through study completion, at least 5 and up to 8 years
measure: Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use)
timeFrame: 5 years ; up to 8-year after index procedure
measure: Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use)
timeFrame: 5 years ; up to 8-year after index procedure
measure: Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use)
timeFrame: 5 years ; up to 8-year after index procedure
measure: Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention
timeFrame: 6 months after surgical reintervention
measure: Number of Adverse Device Effect
timeFrame: through study completion, at least 5 and up to 8 years
measure: Percentage of Adverse Device Effect
timeFrame: through study completion, at least 5 and up to 8 years
measure: Number of Restorelle mesh Device Deficiencies
timeFrame: through study completion, at least 5 and up to 8 years
measure: Percentage of Restorelle mesh Device Deficiencies
timeFrame: through study completion, at least 5 and up to 8 years
measure: Description of Restorelle mesh Device Deficiencies
timeFrame: through study completion, at least 5 and up to 8 years
measure: Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire
timeFrame: through study completion, at least 5 and up to 8 years
measure: Changes of prolapse symptoms
timeFrame: Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
measure: Prolapse symptoms - number
timeFrame: 12 months ; 5 years
measure: Prolapse symptoms - percentage
timeFrame: 12 months ; 5 years
measure: Assessment of health related quality of life using the EQ-5D-5L questionnaire
timeFrame: Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
measure: Assessment of health related quality of life using the PFIQ-7 questionnaire
timeFrame: Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
measure: Assessment of the sexual functioning by the PISQ-IR questionnaire
timeFrame: Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
measure: Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active.
timeFrame: Pre-index procedure ; 12 months
measure: Number of patients defining success via patient global impression of improvement (PGI-I) scale
timeFrame: 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
measure: Percentage of patients defining success via patient global impression of improvement (PGI-I) scale
timeFrame: 2 months ;12 months ; Every year (at least 5 and up to 8 years)
measure: Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8).
timeFrame: 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
measure: Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8)
timeFrame: 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
Other outcomes:
Locations:
city: Avranches
country: France
facility: Polyclinique de la Baie
state: Choisir Une Région
city: Bordeaux
country: France
facility: Centre Aliénor d'Aquitaine
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Issoire
country: France
facility: CH Paul Ardier d'Issoire
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Puy-en-Velay
country: France
facility: Clinique Bon Secours
city: Libourne
country: France
facility: CH Général Robert Boulin
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Saint-Grégoire
country: France
facility: CH privé Saint Grégoire
city: Saintes
country: France
facility: CH de Saintonge
Study officials:
affiliation: CH La Rochelle, France
name: Philippe Ferry, Dr
role: PRINCIPAL_INVESTIGATOR
References: