protocolSection identificationModule nctId: NCT06296316, orgStudyIdInfo id: IU022, briefTitle: Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair, acronym: REPAIR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2031-12, completionDateStruct date: 2031-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Coloplast A/S, class: INDUSTRY, collaborators name: International Clinical Trials Association, descriptionModule briefSummary: 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., conditionsModule conditions: Genital Prolapse, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Restorelle Polypropylene Mesh, outcomesModule primaryOutcomes 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, secondaryOutcomes measure: Incidence rate of surgical reintervention related to Restorelle mesh use in patients, secondaryOutcomes measure: Number of patients who have only had surgical reintervention not related to Restorelle mesh use, secondaryOutcomes measure: Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use, secondaryOutcomes measure: Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use), secondaryOutcomes measure: Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use), secondaryOutcomes measure: Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use), secondaryOutcomes measure: Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention, secondaryOutcomes measure: Number of Adverse Device Effect, secondaryOutcomes measure: Percentage of Adverse Device Effect, secondaryOutcomes measure: Number of Restorelle mesh Device Deficiencies, secondaryOutcomes measure: Percentage of Restorelle mesh Device Deficiencies, secondaryOutcomes measure: Description of Restorelle mesh Device Deficiencies, secondaryOutcomes measure: Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire, secondaryOutcomes measure: Changes of prolapse symptoms, secondaryOutcomes measure: Prolapse symptoms - number, secondaryOutcomes measure: Prolapse symptoms - percentage, secondaryOutcomes measure: Assessment of health related quality of life using the EQ-5D-5L questionnaire, secondaryOutcomes measure: Assessment of health related quality of life using the PFIQ-7 questionnaire, secondaryOutcomes measure: Assessment of the sexual functioning by the PISQ-IR questionnaire, secondaryOutcomes measure: Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active., secondaryOutcomes measure: Number of patients defining success via patient global impression of improvement (PGI-I) scale, secondaryOutcomes measure: Percentage of patients defining success via patient global impression of improvement (PGI-I) scale, secondaryOutcomes measure: Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8)., secondaryOutcomes measure: Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Polyclinique de la Baie, status: NOT_YET_RECRUITING, city: Avranches, state: Choisir Une Région, zip: 50300, country: France, contacts name: Frédéric Dubois, Dr, role: CONTACT, contacts name: Frédéric Dubois, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68333, lon: -1.36667, locations facility: Centre Aliénor d'Aquitaine, status: NOT_YET_RECRUITING, city: Bordeaux, zip: 33076, country: France, contacts name: Claude Hocké, Pr, role: CONTACT, contacts name: Claude Hocké, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Pellegrin, status: NOT_YET_RECRUITING, city: Bordeaux, zip: 33076, country: France, contacts name: Grégoire Capon, Dr, role: CONTACT, contacts name: Grégoire Capon, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CH Paul Ardier d'Issoire, status: NOT_YET_RECRUITING, city: Issoire, zip: 63500, country: France, contacts name: Clément Bruhat, Dr, role: CONTACT, contacts name: Clément Bruhat, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Aslam Mansoor, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.55, lon: 3.25, locations facility: CH La Rochelle, status: RECRUITING, city: La Rochelle, zip: 17019, country: France, contacts name: Philippe Ferry, Dr, role: CONTACT, contacts name: Philippe Ferry, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Yannick Thirouard, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.16667, lon: -1.15, locations facility: Clinique Bon Secours, status: RECRUITING, city: Le Puy-en-Velay, zip: 43000, country: France, contacts name: Jacques Philippe Largeron, Dr, role: CONTACT, contacts name: Jacques Philippe Largeron, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Marlène Guandalino, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.04366, lon: 3.88523, locations facility: CH Général Robert Boulin, status: NOT_YET_RECRUITING, city: Libourne, zip: 33505, country: France, contacts name: Michel Briex, Dr, role: CONTACT, contacts name: Michel Briex, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.91667, lon: -0.23333, locations facility: Institut Mutualiste Montsouris, status: NOT_YET_RECRUITING, city: Paris, zip: 75014, country: France, contacts name: Isabelle Sauret, role: CONTACT, contacts name: Christine Louis Sylvestre, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Yael Levy Zauberman, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Camille Baraud, Dr, role: PRINCIPAL_INVESTIGATOR, contacts name: Mathilde Allanche, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CH privé Saint Grégoire, status: NOT_YET_RECRUITING, city: Saint-Grégoire, zip: 35760, country: France, contacts name: Frédéric Dubois, Dr, role: CONTACT, contacts name: Frédéric Dubois, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.15085, lon: -1.68706, locations facility: CH de Saintonge, status: NOT_YET_RECRUITING, city: Saintes, zip: 17108, country: France, contacts name: Damien Emeriau, Dr, role: CONTACT, contacts name: Damien Emeriau, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.75, lon: -0.63333, hasResults: False