American Medical Systems Announces 1,000th Patient Enrolled in PROPPER Registry
Largest Prospective, Multi-Year, Penile Prosthetic Registry Advances Understanding of Real-World Satisfaction with Penile Prostheses For Erectile Dysfunction Patients
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 11 North American sites. It aims to better characterize real-world patient satisfaction and other outcomes among men who are receiving prosthetic implants to treat their erectile dysfunction (ED). All patients enrolled in the registry will be implanted with penile implants manufactured by AMS, the majority of whom will receive the three piece inflatable penile prosthesis (IPP), the AMS 700.
Using data from the registry, ten abstracts have been presented at several medical meetings since 2013. Additionally, a peer reviewed study titled Reservoir Alternate Surgical Implantation Technique: Preliminary Outcomes of Initial PROPPER Study of Low Profile or Spherical Reservoir Implantation in Submuscular Location or Traditional Prevesical Space authored by
"We are pleased to be able to partner with an outstanding group of physician investigators in order to add to the understanding of the safety and performance of our devices as they are utilized in clinical practice. We anticipate that the large number of men enrolled in this study will yield robust results that, once published, will be informative for implanting physicians, referring physicians and for patients," said Dr.
Previous clinical research showed that of ED patients who received a penile implant, 93 percent were satisfied with their device1. Furthermore, in a study of both patients and partners, 92 percent of patients and 96 percent of their partners reported excellent or satisfactory sexual activity2.
"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 effective, world-class treatment options," said Dev Kurdikar, Senior Vice President and General Manager, Men's Health, AMS. "We're very pleased to reach this milestone in the PROPPER registry - the largest prospective study of its kind. Such investments are aligned with our strategic intent of being able to provide physicians, patients and other healthcare system stakeholders with impactful data."
For more information about American Medical Systems' pelvic health solutions for men, visit www.visitams.com.
About PROPPER Registry
The registry (ClinicalTrials.gov Identifier NCT01383018) uses questionnaires as well as direct physician to patient physical examination and history taking, enabling the investigating physicians to prospectively measure patient responses at regular intervals over a one-to five-year period. Several key metrics are being analyzed, including device effectiveness, durability, complications and patient satisfaction; quality of life will also be analyzed, as defined though several validated patient questionnaires.
About Erectile Dysfunction
About 1 in 5 American men over the age of 20 experience some degree of ED3, adding up to an estimated 30 million men4. For many patients, drugs and other therapies are not a satisfying option with treatment discontinuation rates of up to 60%. Penile implants, first invented and developed at AMS, have helped more than 300,000 men return to an active and satisfying sex life5 over the past 40 years6.
About the AMS 700™ Series Penile Prosthesis Product Line
The AMS 700™ Series Penile Prosthesis product line is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). These devices are contraindicated in patients who have active urogenital infections or active skin infections in the region of surgery or (for the AMS 700™ Penile Prosthesis with InhibiZone™ Antibiotic Surface Treatment) have a known sensitivity or allergy to rifampin, minocycline, or other tetracyclines. Implantation will make latent natural or spontaneous erections, as well as other interventional treatment options, impossible. Men with diabetes, spinal cord injuries or open sores may have an increased risk of infection.
About American Medical Systems
American Medical Systems (AMS), headquartered in Minnetonka, MN, is a diversified supplier of medical device technology to treat incontinence, sexual dysfunction, benign prostatic hyperplasia (BPH) and other pelvic disorders. AMS is focused on improving access and outcomes with the goal of restoring patient quality of life. AMS is an operating company of
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect
- Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function in patients treated with sildenafil, intracavernous prostaglandin E1 and penile implant surgery for erectile dysfunctions in urology practice.. J Urol. 2003;170:159-163.
- Montorsi F, Rigatti P, Carmignani G, et al. AMS three-piece inflatable implants for erectile dysfunction: a long-term multi-institutional study in 200 consecutive patients. Eur Urol. 2000;37(1):50-55.
- Selvin E, Burnett A, Platz E. Prevalence and risk factors for erectile dysfunction in the U.S. Am J Med. 2007;(120):151-157
- Erectile dysfunction. http://kidney.niddk.nih.gov/KUDiseases/pubs/ED/ErectileDysfunction_508.pdf. National Kidney and Urologic Diseases Information Clearinghouse Web site. Downloaded
January 21, 2013.
- Penile prosthesis.http://www.essm.org/society/esha/malesd/oraltreatments/penileprosthesis.html.
European Society for Sexual Medicine(ESSM) Web site. Downloaded January 1, 2013.
- Scott FB, Bradley WE, Timm GW. Management of erectile impotence: use of implantable inflatable prosthesis. Urology. 1973;2(1):80-82.
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