Materiovigilance After Urinary Incontinence or Prolapse Surgery (VIGI-MESH)

Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.

Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.

Study Overview

• Status: Active, not recruiting
• Conditions: Pelvic Organ Prolapse; Urinary Stress Incontinence; Rectal Prolapse
• Intervention / Treatment: Procedure: urinary incontinence, pelvic organ or rectal prolapse surgery

Detailed Description

RATIONAL Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.

MAIN OBJECTIVE Estimate the incidence of severe complications during or after surgery of urinary incontinence or pelvic organ prolapse in adult women depending on the type of surgery performed.

SECONDARY OBJECTIVES Estimate the incidence of severe complications after urinary incontinence or prolapse surgery as a function of time since surgery.

Compare the incidence rates of severe complications considering the type of procedure (with or without mesh, vaginal or laparoscopic, etc.), comorbidities, mesh type, surgeon experience, and surgical volume centre.

Report the health and satisfaction of operated women. Estimate the risk of revision surgery for failure or recurrence.

MAIN OUTCOME Per- and post-operative complications (less than 12 months after surgery), or late (after 12 months) severe (grade III or higher according to the Clavien-Dindo classification)

OTHER OUTCOMES Time lapse of occurrence of severe complications Surgical recovery for failure or recurrence Health and perceived improvement (OMS, EQ5D, an PGI-I questionnaires)

DESIGN Prospective multicentre cohort allowing the constitution and analysis of an observatory off surgery for genital prolapse, rectal prolapse and urinary stress incontinence in women.

INCLUSION CRITERIA

• Operated for urinary incontinence, genital prolapse, or rectal prolapse in one of the centres participating in the observatory
• 18 years old or more.

SUBJECTS NUMBER Estimated at 3000 per year during 5 years in 18 participating centres

STUDY LENGTH Duration of the inclusion period: 2 years with the initial grant from ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé, French Medicines and Healthcare Products Regulatory Agency), after new funding by ANSM 5 years of inclusion in total.

Duration of participation of subjects: 2 years with grant from ANSM, after the new funding by ANSM 10 years.

Total duration of the study: 3 years with the grant from ANSM, 15 years with the new funding.

ANALYSIS PLANNED The one-year analysis will be based on multivariate logistic regression analysis (considering confounding factors). The 10-year (or intermediate-term) analysis will use survival analysis methods to account for delays in complications: Kaplan-Meier curves; Model of Cox proportional hazards.

PERSPECTIVES The observatory should make it possible to precise the tolerance and the short- and long-term consequences of the use of these implantable devices (meshes) in pelvic organ prolapse or incontinence surgery in women and to specify the risk factors for severe complications.

The observatory will enable to make comparisons between the different types of meshes and different surgical procedures, and to identify those that may present problems.

Clinical practice recommendations may be issued as well as standards for marketing.

• Study Type: Observational
• Enrollment (Actual): 19000

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13090
    • Centre l'Avancée - Clinique Axium
  • Angers, France, 49900
    • C.H.U. d'Angers
  • Besançon, France, 25000
    • CHRU De Besancon
  • Bordeaux, France, 33200
    • CHU de Bordeaux
  • Béthune, France, 62400
    • Centre Hospitalier de Béthune
  • Caen, France, 14033
    • CHU caen
  • Châtellerault, France, 86106
    • Centre Hospitalier Camille Guérin
  • Clamart, France, 92140
    • Hôpital Antoine-Béclère
  • Clermont-Ferrand, France, 630003
    • CHU Estaing
  • Dunkerque, France, 59240
    • Centre Hospitalier de Dunkerque
  • Hénin-Beaumont, France, 62800
    • Polyclinique d'Hénin-Beaumont
  • La Rochelle, France, 17000
    • Hopital La Rochelle- Ré- Aunis
  • Lille, France, 59000
    • Chu Lille
  • Lille, France, 59000
    • Hôpital St Vincent de Paul
  • Limoges, France, 87000
    • CHU de Limoges
  • Lyon, France, 69000
    • Hospices Civils de Lyon
  • Montpellier, France, 34070
    • Clinique Beausoleil
  • Nancy, France, 54511
    • CHRU de NANCY
  • Nantes, France, 44000
    • CHU Nantes
  • Nîmes, France, 30029
    • CHRU Caremeau
  • Paris, France, 75018
    • Hôpital Bichat
  • Paris, France
    • Groupe Hospitalier Diaconesses Croix Saint-Simon
  • Paris, France, 75013
    • La Pitié-Salpétrière
  • Plérin, France, 21900
    • Centre briochin d'Urologie
  • Poissy, France, 78300
    • CHI Poissy-St-Germain
  • Poitiers, France, 86000
    • CHU De Poitiers
  • Reims, France, 51000
    • CHU de Reims
  • Strasbourg, France, 37200
    • CHU Strasbourg
  • Suresnes, France, 92150
    • Hopital Foch
  • Toulon, France, 83000
    • Clinique UROVAR
  • Toulouse, France, 31000
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory, aged 18 years old or more.

Description

Inclusion Criteria:

• Operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory
• 18 years old or more.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe complications	Grade III or more according to Clavien-Dindo classification	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time lapse of occurrence of severe complications		10 years
Surgical recovery for failure or recurrence	Number participent with new revision surgery for failure Number participent with new revision surgery for recurrence	10 years
Health and perceived improvement	Scale OMS/ ECOG Eastern Cooperative Oncology Groupone covers six values, from 0 to 5, where 0 represents a good state of health and 5 the death.	10 years
Health and perceived improvement	EQ5D is a standardised measure of health status developed Each of the 5 dimensions comprising the EQ-5D descriptive system is divided into 5 levels of perceived problems : Level 1 : indicating no problem; Level 2 : indicating slight problems; Level 3 : indicating moderate problems; Level 4 : indicating severe problems; Level 5 : indicating extreme problems	10 years
Health and perceived improvement	PGI-I, Patient Global Impression of Improvement, is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.	10 years

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Collaborators: Agence Nationale de sécurité du Médicament
• Investigators: Principal Investigator: Xavier FRITEL, PhD, MD, Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): May 1, 2033

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: surgery; medical devices (meshes)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis; Urinary Incontinence, Stress; Rectal Prolapse
• Other Study ID Numbers: 2016-A01868-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No