The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Study Overview
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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.

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.

Official Title
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Safety and Efficacy of Transvaginal Mesh Colposuspension for Anterior Vaginal Prolapse: the Elevate vs. Anterior Colporrhaphy Trial

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Procedure: Elevate Mesh
* Procedure: Anterior Colporrhaphy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Elevate Mesh<br>Elevate transvaginal mesh - surgical repair of prolapse | Procedure: Elevate Mesh<br>* Transvaginal mesh repair of anterior vaginal prolapse<br>|
| Active Comparator: Anterior Colporrhaphy<br>Anterior colporrhaphy - surgical repair of prolapse | Procedure: Anterior Colporrhaphy<br>* Traditional suture repair of anterior vaginal prolapse<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystocele, Bladder prolapse, Anterior prolapse, Vaginal prolapse, Uterine prolapse, Urinary incontinence