The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

Elegant [NCT01497171]

Description: 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.

Device: Elevate® Transvaginal Mesh; Procedure: Anterior Colporrhaphy

Primary Investigator: Karram

Drug/Device Information
Vaginal pelvic organ prolapse
Elevate® Transvaginal Mesh vs. Anterior Colporrhaphy
Phase IV
Emanuel Trabuco and American Medical Systems
Major Inclusion and Exclusion
Women age 21-80 with symptomatic pelvic organ prolapse
Must require apical and anterior compartment repairs
No interstitial cystitis or chronic pelvic pain
No malignancy, prior radiation or mesh repair