MINNEAPOLIS, May 12, 2011 /PRNewswire/ -- American Medical Systems® (AMS) a leading provider of world-class devices and therapies for male and female pelvic health, announced today the signing of a research grant contract for six sites to evaluate anatomical, functional and safety outcomes of two different treatments for vaginal prolapse, Anterior Colporrhaphy, a technique which uses traditional suture plication, versus the Elevate® Anterior and Apical Prolapse Repair System.
"This pivotal study encompasses a highly scientific-based approach bringing together some of the most respected physicians in the country," said John Nealon, Senior Vice President and General Manager at AMS. "This trial reinforces AMS' commitment to producing high-caliber scientific data, giving physicians the confidence in knowing they have selected the most appropriate technique for treating their patients."
Previous studies of mesh reinforced repairs have focused primarily on vaginal anatomy. The goal of this study is to more thoroughly address vaginal and lower urinary tract function in addition to safety and efficacy. 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 study, which will include a total of 214 patients, will be prospective, randomized, single blinded, and conducted at six participating centers. Mayo Clinic is the managing site for the study and has selected the six independent implanting sites which it will manage throughout the study including one located in Germany and five in the United States. The first patient enrollment is targeted for the second half of 2011.Elevate is a minimally invasive, comprehensive solution 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. Elevate is the top-selling vaginal mesh kit on the market and since its introduction in 2008, more than 35,000 patients have been treated.