The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01497171
Recruitment Status : Terminated (Early termination of study due to changes in funding.)
First Posted : December 22, 2011
Results First Posted : August 21, 2014
Last Update Posted : August 21, 2014
American Medical Systems
Information provided by (Responsible Party):
Emanuel Trabuco, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Procedure: Elevate Mesh Procedure: Anterior Colporrhaphy Phase 4

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  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial
Study Start Date : November 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01497171

United States, California
Kaiser-Permanente - North Valley
Roseville, California, United States, 95661
Kaiser-Permanente - Santa Clara
Santa Clara, California, United States, 95051
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, District of Columbia
Washington Hospital Center - MedStar Health
Washington, District of Columbia, United States, 20010
United States, Ohio
The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States, 45219
St. Hedwig's Krankenhaus
Berlin, Germany, 10115
Sponsors and Collaborators
Emanuel Trabuco
American Medical Systems
Principal Investigator: Emanuel Trabuco, MD Mayo Clinic

Responsible Party: Emanuel Trabuco, Assistant Professor of Obstetrics-Gynegology, Consultant-OB/Gyn Surgery, Mayo Clinic Identifier: NCT01497171     History of Changes
Other Study ID Numbers: 11-000247
First Posted: December 22, 2011    Key Record Dates
Results First Posted: August 21, 2014
Last Update Posted: August 21, 2014
Last Verified: August 2014

Keywords provided by Emanuel Trabuco, Mayo Clinic:
Bladder prolapse
Anterior prolapse
Vaginal prolapse
Uterine prolapse
Urinary incontinence

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female