The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Emanuel Trabuco

Status and phase: Terminated; Phase 4

Conditions: Pelvic Organ Prolapse

Treatments: Procedure: Anterior Colporrhaphy; Procedure: Elevate Mesh

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01497171

11-000247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

Elevate Mesh

Active Comparator group

Description:

Elevate transvaginal mesh - surgical repair of prolapse

Treatment:

Procedure: Elevate Mesh

Anterior Colporrhaphy

Active Comparator group

Description:

Anterior colporrhaphy - surgical repair of prolapse

Treatment:

Procedure: Anterior Colporrhaphy