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June 15, 2011 /PRNewswire/ --
American Medical Systems® (AMS) (NASDAQ: AMMD), a leading provider of world-class devices and therapies for male and female pelvic health, announced today the commencement of a major global registry of penile prosthetic outcomes. The registry, entitled PROPPER (Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration), is led by a team of prominent urologists seeking to better characterize patient satisfaction associated with modern penile prosthetic implants.
PROPPER is a large-scale observational registry expected to enroll over 1,000 men diagnosed with erectile dysfunction (ED) for whom an AMS penile prosthesis is recommended by their physician. Initially, over ten sites will be involved in the research.
Patient enrollment has started and
Gerard D. Henry, MD, of Regional Urology in
Shreveport, LA, was one of the first investigators to enroll. "This registry is the first of its kind," he explained. "I am excited about these outcome measures that will add to the scientific literature and ultimately allow patients and healthcare professionals to continue to make informed choices on treatment options."
The PROPPER registry seeks to better understand real-world outcomes for men undergoing penile implant surgery to treat erectile dysfunction. Using questionnaires as well as electronic data collection, investigating physicians will prospectively measure patient responses at regular intervals over a one- to five-year period. The physician researchers have identified key metrics for the study including device effectiveness, durability, complications and patient satisfaction; quality of life will also be analyzed, being defined through several validated patient surveys.
"American Medical Systems is pleased to be making the PROPPER registry possible. We believe this program will play an important role in both clinical development and physician-patient decision making," said
Whitney D. Erickson, Senior Vice President, General Manager Men's Health, American Medical Systems. "PROPPER demonstrates AMS' commitment to assisting patients and healthcare professionals by working closely with urologists to conduct objective and meaningful research."
Results from the PROPPER registry will be published by the researchers, with the initial outcomes expected to be made public in 2013.