VIGI-MESH: Materiovigilance After Urinary Incontinence or Prolapse Surgery

Sponsor

Poitiers University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03052985

Collaborator

Agence Nationale de sécurité du Médicament (Other)

10,000

Enrollment

Locations

204

Anticipated Duration (Months)

322.6

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Rectal Prolapse Urinary Stress Incontinence	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 14, 2017

Anticipated Primary Completion Date :

Feb 14, 2024

Anticipated Study Completion Date :

Feb 14, 2034

Outcome Measures

Primary Outcome Measures

Incidence of severe complications [10 years]
Grade III or more according to Clavien-Dindo classification

Secondary Outcome Measures

Time lapse of occurrence of severe complications [10 years]
Surgical recovery for failure or recurrence [10 years]
Number participent with new revision surgery for failure Number participent with new revision surgery for recurrence
Health and perceived improvement [10 years]
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.
Health and perceived improvement [10 years]
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre l'Avancée - Clinique Axium	Aix-en-Provence	France	13090
2	C.H.U. d'Angers	Angers	France	49900
3	CHRU de Besançon	Besançon	France	25000
4	CHU de Bordeaux	Bordeaux	France	33200
5	Centre Hospitalier de Béthune	Béthune	France	62400
6	CHU Caen	Caen	France	14033
7	Centre Hospitalier Camille Guérin	Châtellerault	France	86106
8	Hôpital Antoine-Béclère	Clamart	France	92140
9	Chu Estaing	Clermont-Ferrand	France	630003
10	Centre Hospitalier de Dunkerque	Dunkerque	France	59240
11	Polyclinique d'Hénin-Beaumont	Hénin-Beaumont	France	62800
12	Hopital La Rochelle- Ré- Aunis	La Rochelle	France	17000
13	CHU Lille	Lille	France	59000
14	Hôpital St Vincent De Paul	Lille	France	59000
15	CHU de Limoges	Limoges	France	87000
16	Hospices Civils de Lyon	Lyon	France	69000
17	Clinique BEAUSOLEIL	Montpellier	France	34070
18	CHRU de NANCY	Nancy	France	54511
19	CHU Nantes	Nantes	France	44000
20	CHRU Carémeau	Nîmes	France	30029
21	La Pitié-Salpêtrière	Paris	France	75013
22	Hôpital Bichat	Paris	France	75018
23	Groupe Hospitalier Diaconesses Croix Saint-Simon	Paris	France
24	Centre briochin d'Urologie	Plérin	France	21900
25	CHI Poissy-St-Germain	Poissy	France	78300
26	CHU de Poitiers	Poitiers	France	86000
27	CHU de Reims	Reims	France	51000
28	CHU Strasbourg	Strasbourg	France	37200
29	Hopital Foch	Suresnes	France	92150
30	Clinique UROVAR	Toulon	France	83000
31	CHU de Toulouse	Toulouse	France	31000