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

Not Applicable

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT02536001
• Lead Sponsor: Ziv Hospital

Brief 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.

Detailed 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 Timeline

• Status Verified: 2015-05
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-08-26
• Last Update Submitted: 2015-08-26
• Study First Posted: 2015-08-31
• Last Update Posted: 2015-08-31
• Study Start: 2015-09
• Primary Completion: 2017-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complications rate	2 years	comparing complications rate between groups
Sexual function	2 years	use validated questionnaires before and after surgery
Vaginal length between the arms	2 years	measure total vaginal length after surgery
Quality of life	2 years	use validated questionnaires before and after surgery

Secondary Outcome Measures

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