Clinical trial NCT02536001: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Vaginal mesh
Total vaginal length
Quality of life
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2015-08-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vaginal length between the arms
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
measure: Complications rate
timeFrame: 2 years
measure: Sexual function
timeFrame: 2 years
Secondary outcomes:
measure: To examine anatomical results
timeFrame: 2 years
measure: Success rate of uterus preservation
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Ziv Medical center, Israel
name: Naama Marcus Braun, MD
role: STUDY_CHAIR
References: