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

NCT02536001 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-08-31

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

One mesh Endofast reliant system

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

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

Sponsors & Collaborators

  • Ziv Hospital

    lead OTHER_GOV

Principal Investigators

  • Naama Marcus Braun, MD · Ziv Medical center, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-07-31
Completion
2018-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02536001 on ClinicalTrials.gov