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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02536001
• Other study ID #: 0032-15-ZIV
• Status: Not yet recruiting
• Phase: N/A
• First received: July 6, 2015
• Last updated: August 26, 2015
• Start date: September 2015
• Est. completion date: July 2018

Study information

• Verified date: May 2015
• Source: Ziv Hospital
• Contact: Naama Marcus braun, MD
• Phone: +972506266090
• Email: naama.m[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal length between the arms	measure total vaginal length after surgery	2 years	No
Primary	Quality of life	use validated questionnaires before and after surgery	2 years	No
Primary	Complications rate	comparing complications rate between groups	2 years	No
Primary	Sexual function	use validated questionnaires before and after surgery	2 years	No
Secondary	To examine anatomical results	use POP-Q and compare between the groups	2 years	No
Secondary	Success rate of uterus preservation	success will be define as no bulge symptoms and	2 years	No