American Medical Systems has signed a research grant contract for six sites to evaluate anatomical, functional and safety outcomes of two vaginal prolapse treatments - Anterior Colporrhaphy, a technique which uses traditional suture plication, versus the Elevate Anterior and Apical Prolapse Repair System
The goal of the study is to address vaginal and lower urinary tract function in addition to safety and efficacy.
The study includes a total of 214 patients, will be prospective, randomized, single blinded, and conducted at six participating centers.
Upon completion of 12 and 24 months follow up, the objective is to have evidence for guiding the selection of the optimal surgical procedure for patients undergoing transvaginal prolapse repairs.
The first patient enrollment is targeted for the second half of 2011.
Elevate is a minimally invasive technique to treat anterior and apical defects.
The total transvaginal approach is designed to minimize tissue trauma by offering safe, simple and precise apical mesh placement in the sacrospinous ligament and obturator internus muscle through a single vaginal incision.