The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Phase 4

Terminated

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Elevate Mesh; Procedure: Anterior Colporrhaphy

• Registration Number: NCT01497171
• Lead Sponsor: Emanuel Trabuco

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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-08
• Results First Submitted: 2014-08-06
• Results First Submitted QC: 2014-08-06
• Last Update Submitted: 2014-08-06
• Results First Posted: 2014-08-21
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elevate Mesh	Elevate Mesh	Elevate transvaginal mesh - surgical repair of prolapse
Anterior Colporrhaphy	Anterior Colporrhaphy	Anterior colporrhaphy - surgical repair of prolapse

Primary Outcome Measures

Name	Time	Method
Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.	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.

Trial Locations

Locations (6)

Kaiser-Permanente - North Valley; 🇺🇸 Roseville, California, United States

Kaiser-Permanente - Santa Clara; 🇺🇸 Santa Clara, California, United States

Washington Hospital Center - MedStar Health; 🇺🇸 Washington, District of Columbia, United States

The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

St. Hedwig's Krankenhaus; 🇩🇪 Berlin, Germany

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States