The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

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: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Elevate Mesh; Procedure: Anterior Colporrhaphy

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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

• Sponsor: Emanuel Trabuco
• Collaborators: American Medical Systems
• Investigators: Principal Investigator: Emanuel Trabuco, MD, Mayo Clinic

Study record dates

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: Urinary incontinence; Cystocele; Bladder prolapse; Anterior prolapse; Vaginal prolapse; Uterine prolapse
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• 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