Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed ID
DRRC (Other), Medtronic - MITG (Industry)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ugytex

Study Design

Study Type:
Actual Enrollment :
162 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Comparison of the Prosthesis Ugytex by the Trans-obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: Ugytex

Anterior repair reinforced by a specially designed mesh: UgytexTM

Device: Ugytex
Anterior repair reinforced by a specially designed mesh: UgytexTM

No Intervention: No device

standard anterior colporrhaphy

Outcome Measures

Primary Outcome Measures

  1. number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system) [1 year]

    POP-Q score

Secondary Outcome Measures

  1. Perioperative and postoperative morbidity [3 years]

    Number of Major and minor complication

  2. Functionnal results following intervention [3 years]

    Symptoms and quality of life questionnaires

  3. Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage) [3 years]

  4. Post-operative sexuality [3 years]

    PISQ score

Eligibility Criteria


Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Patients older than 60 years-old

  • Anterior vaginal wall prolapse of stage 2 or more (POP-Q system)

  • Symptomatic prolapse

  • Informed consent signature obtained

Exclusion Criteria:
  • Patient not able to read French language

  • Patient with a anterior prolapse of stage 1

  • Urinary of vaginal infection

  • Hepatopathy with ascitis

  • Diabetes uncontrolled

  • Treatment by corticosteroids

  • Previous pelvic irradiation

  • Intraoperative bladder injury

Contacts and Locations


Site City State Country Postal Code
1 Hôpital Carémeau Nimes France 30000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes
  • DRRC
  • Medtronic - MITG


  • Study Director: Hervé Fernandez, MD, Hôpital Béclère, Clamart, France

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes Identifier:
Other Study ID Numbers:
  • P040306
  • CRC04001
First Posted:
Sep 12, 2005
Last Update Posted:
Nov 21, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2019