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

Pelvic Organ Prolapse Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02536001
Study type Interventional
Source Ziv Hospital
Contact Naama Marcus braun, MD
Phone +972506266090
Email naama.m@ziv.health.gov.il
Status Not yet recruiting
Phase N/A
Start date September 2015
Completion date July 2018
View Details
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