The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Phase 4TerminatedNCT01497171

Emanuel Trabuco5 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

Elevate MeshPROCEDURE

Transvaginal mesh repair of anterior vaginal prolapse

Anterior ColporrhaphyPROCEDURE

Traditional suture repair of anterior vaginal prolapse

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

Kaiser-Permanente - North Valley

Roseville, California, United States

Kaiser-Permanente - Santa Clara

Santa Clara, California, United States

Stanford University School of Medicine

Stanford, California, United States

Washington Hospital Center - MedStar Health

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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