The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

August 6, 2014 updated by: Emanuel Trabuco

Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial

This study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, double blinded, randomized controlled trial, comparing Elevate® System with Interpro® Lite™, Anterior and Apical Prolapse Repair System (American Medical Systems) and Anterior Colporrhaphy (anterior suture repair) in women with symptomatic pelvic organ prolapse, who have opted to have surgical repair.

The goals of the study are to compare both efficacy and safety of the two procedures and to compare the surgical impact of mesh and suture repairs on vaginal function.

The principal investigator is from Mayo Clinic in Rochester, Minnesota. Mayo Clinic will serve as the data gathering and coordination site for this multicenter trial.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • St. Hedwig's Krankenhaus
  • United States
    • California
      • Roseville, California, United States, 95661
        • Kaiser-Permanente - North Valley
      • Santa Clara, California, United States, 95051
        • Kaiser-Permanente - Santa Clara
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center - MedStar Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with symptomatic pelvic organ prolapse who opt for a vaginal repair
  • Require both apical and anterior compartment repairs
  • Willing to return for follow-up visit
  • Understand and have signed informed consent to undergo randomization
  • Need both an apical and anterior repair
  • All trial participants who have a uterus will require a hysterectomy

Exclusion Criteria:

  • Known or suspected vulvodynia
  • Known or suspected interstitial cystitis
  • History of chronic pelvic pain
  • Current pregnancy
  • Desire to maintain fertility
  • History of reconstructive pelvic surgery with synthetic mesh
  • History of radical pelvic surgery
  • History of pelvic radiation therapy
  • Currently undergoing treatment for a malignancy
  • Medically poor candidates for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Elevate Mesh
Elevate transvaginal mesh - surgical repair of prolapse
Procedure: Elevate Mesh
Transvaginal mesh repair of anterior vaginal prolapse
Active Comparator: Anterior Colporrhaphy
Anterior colporrhaphy - surgical repair of prolapse
Procedure: Anterior Colporrhaphy
Traditional suture repair of anterior vaginal prolapse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.
Time Frame: 12 months
Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emanuel Trabuco

Collaborators

American Medical Systems

Investigators

  • Principal Investigator: Emanuel Trabuco, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 22, 2011

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-000247

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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