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

NCT ID: NCT02536001

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-07-31

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.

Conditions

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Pelvic Organ Prolapse

Keywords

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Vaginal mesh Total vaginal length Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type OTHER

One mesh Endofast reliant system

Intervention Type DEVICE

One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse

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)

Group Type OTHER

two meshes Endofast reliant system

Intervention Type DEVICE

Two meshes (anterior and posterior Endofast reliant system) will be used to correct separately the anterior compartment and the apical compartment

Interventions

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One mesh Endofast reliant system

One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse

Intervention Type 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

Intervention Type DEVICE

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naama Marcus Braun, MD

Role: STUDY_CHAIR

Ziv Medical center, Israel

Central Contacts

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Naama Marcus braun, MD

Role: CONTACT

Phone: +972506266090

Email: [email protected]

Other Identifiers

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0032-15-ZIV

Identifier Type: -

Identifier Source: org_study_id