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