Treatment of pelvic floor dysfunction related issues is what researchers are hoping to advance with new grant contract announced last week. American Medical Systems released a statement on May 12th revealing the contract which will include six different sites to evaluate two treatments for vaginal prolapse, a common pelvic floor dysfunction in women.
"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."
The goal of the study, the statement says, is to fully evaluate the functionality, safety and efficacy of the Anterior Colporrhaphy, Elevate Anterior and Apical Prolapse Repair System. Previous studies have only taken into account vaginal anatomy – not their effects on relieving pelvic floor dysfunction vaginal prolapse.
Researchers expect to begin enrollment of 214 patients for the trials in the later half of 2011. The Mayo Clinic is the main clinic site and there will be four others located around the US and one in Germany.
Current corrective methods for vaginal prolapse include surgical procedures and rehabilitation with pelvic floor physical therapists.