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

Genital Prolapse Clinical Trial

— REPAIR  

Official title:

Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair: an Observational Post-Market Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296316
• Other study ID #: IU022
• Status: Recruiting
• Start date: November 21, 2023
• Est. completion date: December 2031

Study information

• Verified date: February 2024
• Source: Coloplast A/S
• Contact: Martine Dehez
• Phone: +33 6 34 40 83 40
• Email: frmdeh[@]coloplast.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 428
• Est. completion date: December 2031
• Est. primary completion date: December 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genital Prolapse
• Prolapse

Intervention

Device:
• Restorelle Polypropylene Mesh
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.

Locations

Country	Name	City	State
France	Polyclinique de la Baie	Avranches	Choisir Une Région
France	Centre Aliénor d'Aquitaine	Bordeaux
France	CHU Pellegrin	Bordeaux
France	CH Paul Ardier d'Issoire	Issoire
France	CH La Rochelle	La Rochelle
France	Clinique Bon Secours	Le Puy-en-Velay
France	CH Général Robert Boulin	Libourne
France	Institut Mutualiste Montsouris	Paris
France	CH privé Saint Grégoire	Saint-Grégoire
France	CH de Saintonge	Saintes

Sponsors (2)

Lead Sponsor	Collaborator
Coloplast A/S	International Clinical Trials Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence rate of surgical reintervention related to Restorelle mesh use in patients		through study completion, at least 5 and up to 8 years
Secondary	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
Secondary	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
Secondary	Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use)		5 years ; up to 8-year after index procedure
Secondary	Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use)		5 years ; up to 8-year after index procedure
Secondary	Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use)		5 years ; up to 8-year after index procedure
Secondary	Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention	Patient Global Impression of Improvement (PGI-I) is a 7-point scale that provides a single global measure of condition improvement from 'very much better' to 'very much worse' after treatment. The surgery is defined as successful if the patient felt "very much better" or "much better". In case of reintervention, the patient will complete a PGI-I-Reintervention (same questionnaire as PGI-I) at 6 months after surgical reintervention.	6 months after surgical reintervention
Secondary	Number of Adverse Device Effect		through study completion, at least 5 and up to 8 years
Secondary	Percentage of Adverse Device Effect		through study completion, at least 5 and up to 8 years
Secondary	Number of Restorelle mesh Device Deficiencies		through study completion, at least 5 and up to 8 years
Secondary	Percentage of Restorelle mesh Device Deficiencies		through study completion, at least 5 and up to 8 years
Secondary	Description of Restorelle mesh Device Deficiencies	The description of identified Restorelle mesh Device Deficiencies and categorized according to the association or not with Adverse Device Effect (ADE) or Serious ADE	through study completion, at least 5 and up to 8 years
Secondary	Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire	Post-operative pain will be reported and evaluated by the patient using the modified TOMUS/PREM questionnaire through: Location and Intensity VAS; Pain duration: acute or chronic (more than 6 months); Treatment: types, drug name (if medication) and duration; Persistent pain, beyond 2 weeks, will be defined as having; pain intensity = 40 (VAS) at any of locations (lower abdomen, vagina, lower back and back of legs/buttocks) or during any activity or; pain medication use.	through study completion, at least 5 and up to 8 years
Secondary	Changes of prolapse symptoms	The changes in the Pelvic Floor Disability Index (PFDI-20 questionnaire) total score and sub scores.; Pelvic Floor Distress Inventory (PDFI-20) is comprised of 3 subscales for a total of 20 questions. Each question begins with a "yes" or "no" response. If "yes," the patient must indicate how much bowl, bladder, or pelvic symptoms have been bothering them in the past 3 months on a 4-point scale that ranges from "not at all" (0) to "quite a bit" (4). The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100 (with higher scores indicating more distress/dysfunction). The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.	Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
Secondary	Prolapse symptoms - number	The number of patients rating "yes" at "vaginal bulge" determined by the PFDI-20/POPDI-6 and requiring additional treatment for POP since index procedure	12 months ; 5 years
Secondary	Prolapse symptoms - percentage	The percentage of patients rating "yes" at "vaginal bulge" determined by the PFDI-20/POPDI-6 and requiring additional treatment for POP since index procedure	12 months ; 5 years
Secondary	Assessment of health related quality of life using the EQ-5D-5L questionnaire	The changes in QoL total score using EQ-5D-5L and their evolution. The General Health Outcome Status questionnaire (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions which are divided into 5 levels of perceived problems: from level 1 indicating no problem to level 5 indicating extreme problems. The patient indicates her health state in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, from 'The best health you can imagine' to 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgment.	Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
Secondary	Assessment of health related quality of life using the PFIQ-7 questionnaire	The changes in QoL total score using the Pelvic Floor Impact Questionnaire (PFIQ-7) and their evolution.; Pelvic Floor Impact Questionnaire (PFIQ-7) consists of 7 questions. The responses for each question range from "not at all" (0) to "quite a bit" (3). To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.	Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
Secondary	Assessment of the sexual functioning by the PISQ-IR questionnaire	Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA revised (PISQ-IR): is composed of 20 items including the scales for arousal & orgasm, partner related, condition specific, global quality, condition impact and desire. The number of cases for each scale that can be scored. The mean and standard deviation are provided for each scale.	Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years)
Secondary	Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active.		Pre-index procedure ; 12 months
Secondary	Number of patients defining success via patient global impression of improvement (PGI-I) scale	Patient Global Impression of Improvement (PGI-I) is a 7-point scale that provides a single global measure of condition improvement from 'very much better' to 'very much worse' after treatment. The surgery is defined as successful if the patient felt "very much better" or "much better".	2 months ; 12 months ; Every year (at least 5 and up to 8 years)
Secondary	Percentage of patients defining success via patient global impression of improvement (PGI-I) scale	Patient Global Impression of Improvement (PGI-I) is a 7-point scale that provides a single global measure of condition improvement from 'very much better' to 'very much worse' after treatment. The surgery is defined as successful if the patient felt "very much better" or "much better".	2 months ;12 months ; Every year (at least 5 and up to 8 years)
Secondary	Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8).	Surgical Satisfaction Questionnaire (SSQ-8): is a validated questionnaire used to measure patient satisfaction following a surgery to correct prolapse and/or incontinence. Answers of the SSQ questions consisted of a 5-point scale ranging from "very satisfied" to "very unsatisfied" or from "yes" to "never". Patients' satisfaction is defined if answers correspond with "very satisfied" and "satisfied" or "yes" and "may be".	2 months ; 12 months ; Every year (at least 5 and up to 8 years)
Secondary	Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8)	Surgical Satisfaction Questionnaire (SSQ-8): is a validated questionnaire used to measure patient satisfaction following a surgery to correct prolapse and/or incontinence. Answers of the SSQ questions consisted of a 5-point scale ranging from "very satisfied" to "very unsatisfied" or from "yes" to "never". Patients' satisfaction is defined if answers correspond with "very satisfied" and "satisfied" or "yes" and "may be".	2 months ; 12 months ; Every year (at least 5 and up to 8 years)