The ELEGANT Trial: Elevate Transvaginal Mesh vs. Anterior Colporrhaphy

This is a multicenter, double blinded, randomized controlled trial, comparing Elevate®
System with Intepro® 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 MN. Mayo Clinic will serve as
the data gathering and coordination site for this multicenter trial.

Inclusion Criteria:

- women older than 21 years of age

- with symptomatic pelvic organ prolapse who opt for a vaginal repair

- who require both apical and anterior compartment repairs

- who are willing to return for follow-up visit

- who understand and have signed informed consent to undergo randomization

- all trial participants will 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