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

Poitiers University Hospital

Status: Active, not recruiting

Conditions: Rectal Prolapse; Pelvic Organ Prolapse; Urinary Stress Incontinence

Treatments: Procedure: urinary incontinence, pelvic organ or rectal prolapse surgery

Study type: Observational

Funder types: Other

Identifiers

NCT03052985

2016-A01868-43

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19,000 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.