Step Study Results Demonstrate Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation at 24 Months
MINNEAPOLIS, June 6, 2012 /PRNewswire/ — – Uroplasty, Inc. (NASDAQ:UPI), a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today highlighted 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 a future print edition of Neurourology and Urodynamics and the abstract is now available on line at http://onlinelibrary.wiley.com/doi/10.1002/nau.22266/abstract.
This multi-center trial, led by Dr. M. Kenneth Peters, Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Michigan, followed for up to 24 months patients who initially responded to 12 weekly Urgent PC treatments. There were no device related adverse events throughout the study. With a single Urgent PC treatment at an average of 1.3 times per month, patients continued to experience 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.
“This publication of long term data demonstrates the durability of PTNS therapy and the continued success that patients experience after their initial 12 weekly treatments,” said Dr. Kenneth Peters, lead investigator. “Unlike other treatments for the chronic condition of OAB that require continuous treatment to maintain their effects, this therapy can be administered at approximately monthly intervals to sustain voiding symptom improvement. It is office-based and minimally invasive making it an ideal therapy option for those patients refractory to OAB drug therapy and other conservative therapy.”
“We believe these results support the continued use of Urgent PC to sustain the original success these patients experience,” said Dave Kaysen, President and Chief Executive Officer of Uroplasty, Inc. “We will use this study as part of our efforts to expand awareness of the benefits of Urgent PC with Medicare and commercial Medical Directors.”
About the Urgent® PC Neuromodulation System
The Urgent PC Neuromodulation System is a proprietary, minimally invasive, percutaneous tibial nerve stimulation (PTNS) device designed for office-based treatment of overactive bladder (OAB) and the associated symptoms of urinary urgency, urinary frequency and urge incontinence.
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions. Our primary focus is the commercialization of our Urgent® PC Neuromodulation System, the only FDA-cleared neuromodulation system that delivers percutaneous tibial nerve stimulation for the office-based treatment of overactive bladder and associated symptoms of urgency, frequency and urge incontinence. We also offer Macroplastique® Implants, a urethral bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. Please visit Uroplasty, Inc. at www.uroplasty.com.
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Uroplasty, Inc. EVC Group --------------- --------- David Kaysen, President and CEO, or Jenifer Kirtland (Investors) Medi Jiwani, Vice President, CFO, and Treasurer, 415.568.9349 952.426.6140 Chris Gale (Media) 646.201.5431
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