Study to support Urgent(R) PC clinical success and expanded reimbursement coverage
MINNEAPOLIS, Jan. 26 /PRNewswire-FirstCall/ -- Uroplasty, Inc. (Amex: UPI) announced today the completion of patient enrollment in the randomized, controlled multicenter clinical study of its Urgent PC neuromodulation system for the treatment of overactive bladder (OAB) symptoms of urinary urgency, urge incontinence and frequency of urinary voids. A total of 214 patients have enrolled two months ahead of schedule in the clinical Study of Urgent PC vs. Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) at 22 centers throughout the United States.
The study is designed to directly compare the effectiveness of percutaneous tibial nerve stimulation (PTNS) using Urgent PC to a non-active sham. Uroplasty is undertaking this study primarily to expand and support third-party reimbursement coverage in the U.S. The study will evaluate reductions in urinary urgency, urge incontinence and frequency of urinary voids, as well as patient quality of life measures, and is expected to be completed by early fall of 2009.
'The early completion of enrollment in this trial illustrates the strong physician interest and patient acceptance of PTNS therapy at the participating centers,' said Dr. Kenneth M. Peters, Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Michigan, and the SUmiT study's principal investigator. 'We believe the study's design will deliver to the medical community additional key scientific data on PTNS,' added Dr. Peters.
More than 33 million Americans suffer from OAB symptoms, which dramatically impact the quality of their lives. The Urgent PC system is a minimally invasive, office-based, nonsurgical PTNS device that treats these symptoms. The Company believes physicians, patients and many third party payers have embraced Urgent PC therapy as a clinically effective, low-cost, non-surgical, non-drug treatment alternative.
Dr. Peters, the lead investigator for this study, is internationally known for his work on neuromodulation, interstitial cystitis, and painful bladder syndrome. He has published several studies and written extensively on the effect of neuromodulation for treating voiding dysfunction, interstitial cystitis and pelvic pain, is a peer reviewer for several journals, and lectures internationally on the topic. He has used PTNS routinely for several years in his clinical practice.
'Our goal with the SUmiT study is to expand and support third-party reimbursement coverage for the Urgent PC procedure in the U.S.
