American Medical Systems (AMS), Inc. a subsidiary of Endo Health Solutions Inc. and also a leading provider of devices and therapies for male and female pelvic health, has enrolled 500th patient in the largest multi-year, prospective global registry study of penile prosthetic outcomes in the world.
The study, entitled PROPPER (Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration), is sponsored by AMS and is being conducted by a team of experienced urologists at 14 North American sites. It aims to better characterize real-world patient satisfaction and other outcomes such as device effectiveness and durability among men who are receiving these prosthetic solutions to treat their erectile dysfunction (ED).
Initial results for the first 50 patients implanted with AMS 700 inflatable penile prostheses were presented by Dr Edward Karpman, El Camino Urology Medical Group, Mountain View, California, at the 2013 American Urological Association (AUA) Annual Meeting in May. "PROPPER is the first-of-its kind observational registry that captures critical data about real-life outcomes to aid patients and their doctors in making important decisions about their ED treatment options," said Karpman. "This is an ongoing process, and we expect the database to continue growing as more men, with the support of their partners, consider penile implants."
Additional data from the PROPPER study will be presented at upcoming medical meetings, including sectional meetings of the AUA and the Sexual Medicine Society of North America (SMSNA) Fall Scientific Meeting. The 14 physician investigators are expected to enroll up to 1,000 men diagnosed with erectile dysfunction (ED) in this registry, and follow up with these patients at regular intervals over five years. "We are pleased to be able to partner with these physician investigators in PROPPER and add to the clinical understanding about the safety and performance of our devices in real-life outcomes. While we already have the most number of patients already enrolled in a prospective, multi-year, multi-center, global registry, we intend to continue enrolling patients for the foreseeable future," said Dr Ronald Morton, chief surgical officer, AMS.
In a variety of clinical studies, the percentage of patients moderately satisfied to very satisfied with penile implants ranged from 75-98 per cent. Furthermore, in a study of 200 patients and 120 partners, 92 per cent of patients and 96 per cent of their partners reported excellent or satisfactory sexual activity.
"American Medical Systems, an established world-leader in treatments for ED and other pelvic health disorders, is committed to advancing the treatment of ED, to give men and their partners highly effective, world-class treatment options," said Dev Kurdikar, senior vice president and general manager, Men's Health, American Medical Systems. "We're very pleased to reach this milestone in the PROPPER registry, as we believe strongly that collecting this data to confirm the benefits of our products is critical to future product development."