Comparative Study of Mesh Versus No Mesh in Prolapse Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Vaginal Prolapse, Cystocele

Intervention / Treatment
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* Device: Ugytex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ugytex<br>Anterior repair reinforced by a specially designed mesh: UgytexTM | Device: Ugytex<br>* Anterior repair reinforced by a specially designed mesh: UgytexTM<br>|
| No Intervention: No device<br>standard anterior colporrhaphy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of anatomical recurrences of anterior vaginal wall prolapse of stage 2 or more (POP-Q system) | POP-Q score | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative and postoperative morbidity | Number of Major and minor complication | 3 years | 
| Functionnal results following intervention | Symptoms and quality of life questionnaires | 3 years | 
| Rate of local complications of prosthesis (vaginal erosion, prosthesis shrinkage) |  | 3 years | 
| Post-operative sexuality | PISQ score | 3 years |