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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536001
Recruitment Status : Unknown
Verified May 2015 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Device: One mesh Endofast reliant system Device: two meshes Endofast reliant system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Vaginal length between the arms [ Time Frame: 2 years ]
    measure total vaginal length after surgery

  2. Quality of life [ Time Frame: 2 years ]
    use validated questionnaires before and after surgery

  3. Complications rate [ Time Frame: 2 years ]
    comparing complications rate between groups

  4. Sexual function [ Time Frame: 2 years ]
    use validated questionnaires before and after surgery


Secondary Outcome Measures :
  1. To examine anatomical results [ Time Frame: 2 years ]
    use POP-Q and compare between the groups

  2. Success rate of uterus preservation [ Time Frame: 2 years ]
    success will be define as no bulge symptoms and <stage II



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536001


Contacts
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Contact: Naama Marcus braun, MD +972506266090 naama.m@ziv.health.gov.il

Sponsors and Collaborators
Ziv Hospital
Investigators
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Study Chair: Naama Marcus Braun, MD Ziv Medical center, Israel
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Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT02536001    
Other Study ID Numbers: 0032-15-ZIV
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: May 2015
Keywords provided by Ziv Hospital:
Vaginal mesh
Total vaginal length
Quality of life
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical