Clinical Trial: Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of the Prosthesis Ugytex by the Trans-Obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse.

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.

  1. Julian TM: The efficacy or Marlex mesh i

    Detailed Summary:
    Sponsor: Centre Hospitalier Universitaire de Nīmes

    Current Primary Outcome: Rate of anatomical recurrence of anterior vaginal wall prolapse of stage 2 or more (POP-Q system) , at one year.

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Perioperative morbidity
    • Symptoms and quality of life questionnaires
    • Post-operative sexuality
    • Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage)


    Original Secondary Outcome: Same as current

    Information By: Centre Hospitalier Universitaire de Nīmes

    Dates:
    Date Received: September 8, 2005
    Date Started: June 2005
    Date Completion: June 2011
    Last Updated: September 8, 2005
    Last Verified: September 2005