Step Study Results Demonstrate Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation at 24 Months

Patients treated with Urgent® PC over 2 years sustained the benefits experienced after initial 12 weeks of therapy

Jun 06, 2012, 07:37 ET from Uroplasty, Inc.

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

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

Forward Looking Statements

This press release contains forward looking statements that reflect our best estimates regarding future events and financial performance. These forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our anticipated results. We discuss in detail the factors that may affect the achievement of our forward looking statements in our Annual Report on Form 10-K filed with the SEC.  In particular, we cannot be certain that we will ever achieve sustained profitability; that the rate of reimbursement for PTNS treatments will be adequate to justify the cost of our product; that other Medicare carriers or private payers will provide coverage for this treatment or that existing carriers and payers will not change their coverage decisions; that the rate of adoption of our products by new customers will continue; that we will be able to complete the design and development of, or to manufacture, an implantable device at an effective cost; that clinical trials of that implantable device, or of a fecal incontinence device, will prove favorable; that the data and results of those clinical trials will prove acceptable to the FDA and other regularity bodies or that we will be granted clearance to market the devices; or that even if marketable, we will be able to obtain appropriate reimbursement for the implantable and fecal incontinence devices; or that any of the other risks identified in our 10-K will not adversely affect our expectations as described in these forward looking statements.

For Further Information:

Uroplasty, Inc.

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David Kaysen, President and CEO, or

Jenifer Kirtland (Investors) 

Medi Jiwani, Vice President, CFO, and Treasurer,



Chris Gale (Media)  


SOURCE Uroplasty, Inc.