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

Ziv Hospital

Status: Unknown

Conditions: Pelvic Organ Prolapse

Treatments: Device: One mesh Endofast reliant system; Device: two meshes Endofast reliant system

Study type: Interventional

Funder types: Other

Identifiers

NCT02536001

0032-15-ZIV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

One mesh Endofast reliant system

Other group

Description:

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)

Treatment:

Device: One mesh Endofast reliant system

two meshes Endofast reliant system

Other group

Description:

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)

Treatment:

Device: two meshes Endofast reliant system