May 10 2013
Uroplasty, Inc. (NASDAQ: UPI), a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today highlighted the 3-year results of the STEP Study on percutaneous tibial nerve stimulation (PTNS) treatments for overactive bladder (OAB) using Uroplasty's Urgent® PC Neuromodulation System. The study will be published in the June 2013 print edition of The Journal of Urology and the article is now available on line at www.jurology.com.
Dr. M. Kenneth Peters, Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Michigan, led this multi-center, long term study. Patients who initially responded to 12 weekly Urgent PC treatments were followed for 36 months and received Urgent PC therapy throughout. Patients received an average of 1.1 treatments per month and sustained statistically significant improvements in voiding frequency, urinary urge incontinence episodes, nighttime voids, urgency episodes and voids with moderate to severe urgency, voiding volume and quality of life measures compared to before they began treatment with Urgent PC. There were no serious adverse events reported throughout the study.
"We are pleased that this long-term study demonstrates the durability of the effect of PTNS over 3 years," said Dr. Kenneth Peters , lead investigator. "This study demonstrates that with on-going therapy OAB patients can continue to sustain improvement in their OAB symptoms. This is a chronic condition for which there is currently no cure. With continuing therapy, patients' symptoms can be controlled at a level that positively impacts their quality of life. The recent AUA/SUFU OAB Guidelines affirm that for those patients for whom OAB drug therapy and other conservative therapies have not worked, PTNS is an ideal option."
"PTNS is an established part of the OAB algorithm of care. These long-term results confirm the role of PTNS in providing real benefits to patients," said Nancy Kolb, Uroplasty Vice President of Global Marketing. "This study, along with the many others in the world literature demonstrates that PTNS is effective, safe and durable. Using this study and other data, we will continue to promote the role of PTNS within the OAB paradigm of care."