Last updated on February 2019

Materiovigilance After Urinary Incontinence or Prolapse Surgery


Brief description of study

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 Study 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.

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.

Estimate the number of annual procedures with mesh for the surgery of urinary incontinence, genital prolapse, and rectal prolapse in France.

Estimate the exhaustivity of the current implantable medical device surveillance compared to our reinforced observatory.

Estimate the accuracy of the surgical procedure coding compared to the title of the surgical procedures.

Estimate the cost of surgical treatment of urinary incontinence, genital prolapse and rectal prolapse in France.

MAIN OUTCOME Per- and post-operative complications (less than 12 months after surgery), or late (after 12 months) grade III or higher according to the Clavien-Dindo classification

OTHER OUTCOMES Estimation of the number of hospitalisations in France will use the data of the ATIH (Agence Technique de l'Information sur l'Hospitalisation, French Agency for Information on Hospitalization).

The cost estimate will be based on the analysis of hospital stays (duration and procedures).

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 2000 per year during 5 years in 10 participating centres (3000 per year if the number of centres is increased to 15).

STUDY LENGTH Duration of the inclusion period: 2 years with the initial grant from ANSM (Agence Nationale de Scurit du Mdicament et des produits de sant, French Medicines and Healthcare Products Regulatory Agency), the objective is to obtain an additional funding for 5 years of inclusion in total.

Duration of participation of subjects: 2 years with grant from ANSM, but a period of 10 years would be preferable.

Total duration of the study: 3 years with the grant from ANSM, 15 years if a complementary funding is found.

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 shortand 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.

Clinical Study Identifier: NCT03052985

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Recruitment Status: Open


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