The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Elevate Mesh

Elevate transvaginal mesh - surgical repair of prolapse

Group Type ACTIVE_COMPARATOR

Elevate Mesh

Intervention Type PROCEDURE

Transvaginal mesh repair of anterior vaginal prolapse

Anterior Colporrhaphy

Anterior colporrhaphy - surgical repair of prolapse

Group Type ACTIVE_COMPARATOR

Anterior Colporrhaphy

Intervention Type PROCEDURE

Traditional suture repair of anterior vaginal prolapse

Interventions

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Elevate Mesh

Transvaginal mesh repair of anterior vaginal prolapse

Intervention Type PROCEDURE

Anterior Colporrhaphy

Traditional suture repair of anterior vaginal prolapse

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No