Clinical trial NCT03052985: Materiovigilance After Urinary Incontinence or Prolapse Surgery
Official title: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Organ Prolapse
Rectal Prolapse
Urinary Stress Incontinence
Keywords: medical devices (meshes)
surgery
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Agence Nationale de sécurité du Médicament
First posted: 2017-02-14
Enrollment: 19000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of severe complications
timeFrame: 10 years
Secondary outcomes:
measure: Time lapse of occurrence of severe complications
timeFrame: 10 years
measure: Surgical recovery for failure or recurrence
timeFrame: 10 years
measure: Health and perceived improvement
timeFrame: 10 years
measure: Health and perceived improvement
timeFrame: 10 years
measure: Health and perceived improvement
timeFrame: 10 years
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre l'Avancée - Clinique Axium
city: Angers
country: France
facility: C.H.U. d'Angers
city: Besançon
country: France
facility: CHRU de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Béthune
country: France
facility: Centre Hospitalier de Béthune
city: Caen
country: France
facility: CHU Caen
city: Châtellerault
country: France
facility: Centre Hospitalier Camille Guérin
city: Clamart
country: France
facility: Hôpital Antoine-Béclère
city: Clermont-Ferrand
country: France
facility: Chu Estaing
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Hénin-Beaumont
country: France
facility: Polyclinique d'Hénin-Beaumont
city: La Rochelle
country: France
facility: Hopital La Rochelle- Ré- Aunis
city: Lille
country: France
facility: CHU Lille
city: Lille
country: France
facility: Hôpital St Vincent De Paul
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: Clinique BEAUSOLEIL
city: Nancy
country: France
facility: CHRU de NANCY
city: Nantes
country: France
facility: CHU Nantes
city: Nîmes
country: France
facility: CHRU Carémeau
city: Paris
country: France
facility: La Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
city: Plérin
country: France
facility: Centre briochin d'Urologie
city: Poissy
country: France
facility: CHI Poissy-St-Germain
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: CHU de Reims
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Suresnes
country: France
facility: Hopital Foch
city: Toulon
country: France
facility: Clinique UROVAR
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Poitiers University Hospital
name: Xavier FRITEL, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: