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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02536001
Enrollment
100
Registered
2015-08-31
Start date
2015-09-30
Completion date
2018-07-31
Last updated
2015-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Vaginal mesh, Total vaginal length, Quality of life

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.

Interventions

DEVICEOne mesh Endofast reliant system

One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse

DEVICEtwo 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

Sponsors

Ziv Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Vaginal length between the arms2 yearsmeasure total vaginal length after surgery
Quality of life2 yearsuse validated questionnaires before and after surgery
Complications rate2 yearscomparing complications rate between groups
Sexual function2 yearsuse validated questionnaires before and after surgery

Secondary

MeasureTime frameDescription
To examine anatomical results2 yearsuse POP-Q and compare between the groups
Success rate of uterus preservation2 yearssuccess will be define as no bulge symptoms and \<stage II

Contacts

Primary ContactNaama Marcus braun, MD
naama.m@ziv.health.gov.il+972506266090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026