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

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
One mesh Endofast reliant system
two meshes Endofast reliant system
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Vaginal mesh, Total vaginal length, Quality of life

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    One mesh Endofast reliant system

    two meshes Endofast reliant system

    Arm 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)

    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)

    Outcomes

    Primary Outcome Measures

    Vaginal length between the arms
    measure total vaginal length after surgery
    Quality of life
    use validated questionnaires before and after surgery
    Complications rate
    comparing complications rate between groups
    Sexual function
    use validated questionnaires before and after surgery

    Secondary Outcome Measures

    To examine anatomical results
    use POP-Q and compare between the groups
    Success rate of uterus preservation
    success will be define as no bulge symptoms and <stage II

    Full Information

    First Posted
    July 6, 2015
    Last Updated
    August 26, 2015
    Sponsor
    Ziv Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02536001
    Brief Title
    Prospective Randomized Study to Compare Results of Pelvic Organ Prolapse Repair With One Versus Two Vaginal Meshes
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ziv Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse
    Keywords
    Vaginal mesh, Total vaginal length, Quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    One mesh Endofast reliant system
    Arm Type
    Other
    Arm 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)
    Arm Title
    two meshes Endofast reliant system
    Arm Type
    Other
    Arm 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)
    Intervention Type
    Device
    Intervention Name(s)
    One mesh Endofast reliant system
    Intervention Description
    One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse
    Intervention Type
    Device
    Intervention Name(s)
    two meshes Endofast reliant system
    Intervention Description
    Two meshes (anterior and posterior Endofast reliant system) will be used to correct separately the anterior compartment and the apical compartment
    Primary Outcome Measure Information:
    Title
    Vaginal length between the arms
    Description
    measure total vaginal length after surgery
    Time Frame
    2 years
    Title
    Quality of life
    Description
    use validated questionnaires before and after surgery
    Time Frame
    2 years
    Title
    Complications rate
    Description
    comparing complications rate between groups
    Time Frame
    2 years
    Title
    Sexual function
    Description
    use validated questionnaires before and after surgery
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    To examine anatomical results
    Description
    use POP-Q and compare between the groups
    Time Frame
    2 years
    Title
    Success rate of uterus preservation
    Description
    success will be define as no bulge symptoms and <stage II
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Naama Marcus braun, MD
    Phone
    +972506266090
    Email
    naama.m@ziv.health.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Naama Marcus Braun, MD
    Organizational Affiliation
    Ziv Medical center, Israel
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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