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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: One mesh Endofast reliant system; Device: two meshes Endofast reliant system

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: One mesh Endofast reliant system; 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; One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse
Other: two meshes Endofast reliant system; 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; Two meshes (anterior and posterior Endofast reliant system) will be used to correct separately the anterior compartment and the apical compartment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ziv Hospital
• Investigators: Study Chair: Naama Marcus Braun, MD, Ziv Medical center, Israel

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: August 26, 2015
• First Posted (Estimate): August 31, 2015

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Quality of life; Vaginal mesh; Total vaginal length
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 0032-15-ZIV