Materiovigilance After Urinary Incontinence or Prolapse Surgery

Pelvic Organ Prolapse Clinical Trial

— VIGI-MESH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03052985
• Other study ID #: 2016-A01868-43
• Status: Active, not recruiting
• Start date: February 14, 2017
• Est. completion date: May 1, 2033

Study information

• Verified date: September 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 19000
• Est. completion date: May 1, 2033
• Est. primary completion date: May 1, 2033
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Pelvic Organ Prolapse
• Prolapse
• Rectal Prolapse
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Procedure:
• urinary incontinence, pelvic organ or rectal prolapse surgery
The observatory is planned for following women after surgery for urinary incontinence, pelvic organ prolapse, or rectal prolapse whatever the type of surgery (by laparoscopy, laparotomy or vginal route) or the use of a mesh

Locations

Country	Name	City	State
France	Centre l'Avancée - Clinique Axium	Aix-en-Provence
France	C.H.U. d'Angers	Angers
France	CHRU de Besançon	Besançon
France	Centre Hospitalier de Béthune	Béthune
France	CHU de Bordeaux	Bordeaux
France	CHU Caen	Caen
France	Centre Hospitalier Camille Guérin	Châtellerault
France	Hôpital Antoine-Béclère	Clamart
France	Chu Estaing	Clermont-Ferrand
France	Centre Hospitalier de Dunkerque	Dunkerque
France	Polyclinique d'Hénin-Beaumont	Hénin-Beaumont
France	Hopital La Rochelle- Ré- Aunis	La Rochelle
France	CHU Lille	Lille
France	Hôpital St Vincent De Paul	Lille
France	CHU de Limoges	Limoges
France	Hospices Civils de Lyon	Lyon
France	Clinique BEAUSOLEIL	Montpellier
France	CHRU de NANCY	Nancy
France	CHU Nantes	Nantes
France	CHRU Carémeau	Nîmes
France	Groupe Hospitalier Diaconesses Croix Saint-Simon	Paris
France	Hôpital Bichat	Paris
France	La Pitié-Salpêtrière	Paris
France	Centre briochin d'Urologie	Plérin
France	CHI Poissy-St-Germain	Poissy
France	CHU de Poitiers	Poitiers
France	CHU de Reims	Reims
France	CHU Strasbourg	Strasbourg
France	Hopital Foch	Suresnes
France	Clinique UROVAR	Toulon
France	CHU de Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	Agence Nationale de sécurité du Médicament

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe complications	Grade III or more according to Clavien-Dindo classification	10 years
Secondary	Time lapse of occurrence of severe complications		10 years
Secondary	Surgical recovery for failure or recurrence	Number participent with new revision surgery for failure Number participent with new revision surgery for recurrence	10 years
Secondary	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
Secondary	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
Secondary	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