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Study to support Urgent PC clinical success and expanded reimbursement
coverage
MINNEAPOLIS, Oct. 2 /PRNewswire-FirstCall/ -- Uroplasty, Inc. (Amex: UPI) announced today the enrollment of the first patients in a new randomized, controlled multicenter clinical study of its FDA cleared Urgent PC neuromodulation system for the treatment of overactive bladder (OAB) symptoms of urinary urgency, urge incontinence and frequency of urinary voids.
The study is designed to directly compare the effectiveness of Urgent PC treatment to non-active treatment. Uroplasty is undertaking this study primarily to support third-party reimbursement coverage. The study will evaluate reductions in urinary urgency, urge incontinence and frequency of urinary voids, as well as patient quality of life measures. This study, expected to be completed by early fall of 2009, is to take place at approximately 20 urology and urogynecology centers across the United States, with total enrollment of 214 patients. As previously discussed, Uroplasty has reallocated expenditures this fiscal year to expedite these efforts, and expects to spend between $1.0 million and $1.4 million this fiscal year on the study.
More than 33 million Americans suffer from OAB symptoms, dramatically impacting the quality of their lives. The Urgent PC system is a minimally invasive, office-based, nonsurgical, percutaneous tibial nerve stimulation (PTNS) device that treats these symptoms. The Company believes physicians, patients and many third party payers are embracing the Urgent PC therapy because this low cost, non-surgical, non-drug treatment alternative is clinically effective.
Kenneth M. Peters, M.D., the Principal Investigator leading this study,
is internationally known for his work on neuromodulation, interstitial
cystitis, and painful bladder syndrome. Dr. Peters is the Chairman of the
Department of Urology and Director of Clinical Research -- Depart
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