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Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

NCT00153257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2019-11-21

No results posted yet for this study

Summary

Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy.

Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing's inflammatory peak. Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.

Conditions

  • Vaginal Prolapse
  • Cystocele

Interventions

DEVICE

Ugytex

Anterior repair reinforced by a specially designed mesh: UgytexTM

Sponsors & Collaborators

  • DRRC

    collaborator UNKNOWN

  • Medtronic - MITG

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Hervé Fernandez, MD · Hôpital Béclère, Clamart, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2010-12-31
Completion
2013-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00153257 on ClinicalTrials.gov