Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes
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|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
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse||Device: One mesh Endofast reliant system Device: two meshes Endofast reliant system||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- Vaginal length between the arms [ Time Frame: 2 years ]measure total vaginal length after surgery
- Quality of life [ Time Frame: 2 years ]use validated questionnaires before and after surgery
- Complications rate [ Time Frame: 2 years ]comparing complications rate between groups
- Sexual function [ Time Frame: 2 years ]use validated questionnaires before and after surgery
- To examine anatomical results [ Time Frame: 2 years ]use POP-Q and compare between the groups
- Success rate of uterus preservation [ Time Frame: 2 years ]success will be define as no bulge symptoms and <stage II
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
|Contact: Naama Marcus braun, MDemail@example.com|
|Study Chair:||Naama Marcus Braun, MD||Ziv Medical center, Israel|