Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes

Study Overview
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Brief Summary
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The purpose of this study is to compare anatomical differences, quality of life and sexual function and complications rate between apical support with one anterior vaginal mesh versus repair with two separate meshes.

Detailed Description
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In the presence of stage 3 anterior wall prolapse (cystocele) with second stage apical prolapse (uterine or vault prolapse) there are 2 optional ways to repair with vaginal mesh: (a) to use 2 separated meshes: anterior mesh to correct the anterior compartment and posterior mesh to correct the apical prolapse to the sacrospinous ligament (SSL). (b) To correct both anterior compartment and the apical prolapse with the same mesh while using the posterior arms of the mesh to fix the apical prolapse to the SSL. Each way has its advantages and disadvantages. The first way was described at the beginning of mesh use and might be more anatomical then the second newest way. The addition of apical support to the anterior mesh might theoretically shorten the vagina. There are several recent studies describing the anatomical outcomes both for anterior compartment and apical compartment with a single mesh. Mesh-related complications, which can be also related to the amount of vaginal meshes, can potentially decrease with one mesh as compare with 2 meshes. The aim of the study: If the anatomical results, vaginal length and quality of life, will be with no significant differences between the two groups, the investigators will recommend to use a single mesh, in order to avoid / minimize potential complications of vaginal mesh. If there will be no differences in complications in both groups but will be a significant difference in vaginal length and sexual function, the investigators will recommend using two meshes.

Official Title
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Prospective Randomized Study to Compare Anatomical, Functional and Sexual Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes While Preserving the Uterus

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: One mesh Endofast reliant system
* Device: two meshes Endofast reliant system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least anterior compartment prolapse stage III and uterine prolapse stage II. Exclusion Criteria: Women without uterine prolapse, or with uterine prolapse < stage 2. Women with uterine prolapse > stage 2. Hysterectomy in the past. Women with an indication for hysterectomy.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: One mesh Endofast reliant system<br>Patients with anterior compartment stage III and uterus prolapse grade II will be treated with one mesh - Anterior Endofast reliant system (fixation of posterior arms to the sacrospinous ligament) | Device: One mesh Endofast reliant system<br>* One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse<br>|
| Other: two meshes Endofast reliant system<br>intervention: Patients with anterior compartment stage III and uterus prolapse grade II will be treated with 2 meshes: anterior Endofast reliant system mesh to correct the anterior compartment and posterior Endofast reliant system mesh to correct the apical prolapse (fixation to the sacrospinous ligament) | Device: two meshes Endofast reliant system<br>* Two meshes (anterior and posterior Endofast reliant system) will be used to correct separately the anterior compartment and the apical compartment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal length between the arms | measure total vaginal length after surgery | 2 years | 
| Quality of life | use validated questionnaires before and after surgery | 2 years | 
| Complications rate | comparing complications rate between groups | 2 years | 
| Sexual function | use validated questionnaires before and after surgery | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine anatomical results | use POP-Q and compare between the groups | 2 years | 
| Success rate of uterus preservation | success will be define as no bulge symptoms and <stage II | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal mesh, Total vaginal length, Quality of life