Materiovigilance After Urinary Incontinence or Prolapse Surgery
- Conditions
- Pelvic Organ ProlapseUrinary Stress IncontinenceRectal Prolapse
- Registration Number
- NCT03052985
- Lead Sponsor
- Poitiers University Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 19000
- Operated for urinary incontinence, pelvic organ prolapse, or rectal prolapse in one of the centres participating in the observatory
- 18 years old or more.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of severe complications 10 years Grade III or more according to Clavien-Dindo classification
- Secondary Outcome Measures
Name Time Method Surgical recovery for failure or recurrence 10 years Number participent with new revision surgery for failure Number participent with new revision surgery for recurrence
Time lapse of occurrence of severe complications 10 years Health and perceived improvement 10 years 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.
Trial Locations
- Locations (31)
CHRU de Besançon
🇫🇷Besançon, France
CHU Lille
🇫🇷Lille, France
Hospices Civils de Lyon
🇫🇷Lyon, France
CHU de Limoges
🇫🇷Limoges, France
CHU Strasbourg
🇫🇷Strasbourg, France
Clinique UROVAR
🇫🇷Toulon, France
Centre l'Avancée - Clinique Axium
🇫🇷Aix-en-Provence, France
C.H.U. d'Angers
🇫🇷Angers, France
Centre Hospitalier de Béthune
🇫🇷Béthune, France
CHU Caen
🇫🇷Caen, France
CHU de Bordeaux
🇫🇷Bordeaux, France
Centre Hospitalier de Dunkerque
🇫🇷Dunkerque, France
Polyclinique d'Hénin-Beaumont
🇫🇷Hénin-Beaumont, France
Hôpital St Vincent De Paul
🇫🇷Lille, France
Centre Hospitalier Camille Guérin
🇫🇷Châtellerault, France
Hôpital Antoine-Béclère
🇫🇷Clamart, France
Hopital La Rochelle- Ré- Aunis
🇫🇷La Rochelle, France
CHU Nantes
🇫🇷Nantes, France
CHRU Carémeau
🇫🇷Nîmes, France
Chu Estaing
🇫🇷Clermont-Ferrand, France
Clinique BEAUSOLEIL
🇫🇷Montpellier, France
CHRU de NANCY
🇫🇷Nancy, France
Groupe Hospitalier Diaconesses Croix Saint-Simon
🇫🇷Paris, France
Centre briochin d'Urologie
🇫🇷Plérin, France
CHI Poissy-St-Germain
🇫🇷Poissy, France
CHU de Poitiers
🇫🇷Poitiers, France
Hopital Foch
🇫🇷Suresnes, France
CHU de Toulouse
🇫🇷Toulouse, France
CHU de Reims
🇫🇷Reims, France
Hôpital Bichat
🇫🇷Paris, France
La Pitié-Salpêtrière
🇫🇷Paris, France