Uroplasty, Inc. Release: Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Receives Affirmation of Efficacy and Safety in Agency for Healthcare Research and Quality (AHRQ) Report

MINNEAPOLIS, April 16, 2012 /PRNewswire/ -- Uroplasty, Inc. (NASDAQ: UPI) announced today that the United States Agency for Healthcare Research and Quality (AHRQ) in a recently issued document titled “Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness” included favorable statements on the safety and effectiveness of percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB). Uroplasty’s Urgent®PC Neuromodulation System is currently the only FDA-cleared product in the U.S. that delivers PTNS.

“The report’s positive statements affirm that PTNS is efficacious in reducing the symptoms of OAB, including urinary incontinence (UI), without significant side effects,” said David Kaysen, President and CEO of Uroplasty. “This report clearly states that PTNS is a viable option for treating patients with this chronic condition, especially for those who have tried and failed OAB drugs and other conservative therapies. We will use this positive report in our on-going discussions with Medicare and commercial-payer Medical Directors.”

AHRQ Statements About PTNS:

• Percutaneous tibial nerve stimulation improved UI in adults with OAB.
• Four randomized control trials (RCTs) examined the clinical effects of PTNS including the Study of Urgent PC versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) trial and the Overactive Bladder Innovative Therapy Trial (OrBIT), comparing Urgent PC to the number one pharmacological treatment for OAB.
• Continence rates were 94% among women with predominant urgency UI and 91% in women with mixed UI in an uncontrolled trial.
• Participants in the randomized OrBIT Trial experienced 76 - 80% improvement rates with 12 months of PTNS therapy.
• AHRQ stated that the few RCTs that compared clinical outcomes between nonpharmacological treatments and drugs found similar effectiveness but better safety with nondrug interventions. This finding is significant, considering that side effects from drugs were common and frequently bothersome enough to negatively affect treatment compliance and continuation.
• Nonrandomized studies reported 63 - 64% success rates with PTNS.
• Mild and transient PTNS adverse events were minimal and not statistically significant compared to sham stimulation.

Mr. Kaysen continued, “This positive review by AHRQ supports our position that the Urgent PC system provides physicians, patients and payers with a safe and effective option for the treatment of OAB symptoms. We are also working with national and international professional societies for their support to include PTNS in their treatment algorithms of care for OAB.”

About AHRQ

The Agency for Healthcare Research and Quality (AHRQ) conducts the Effective Health Care Program as part of its mission to organize knowledge and make it available to inform decisions about health care. As part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Congress directed AHRQ to conduct and support research on the comparative outcomes, clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services to meet the needs of Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP).

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 focus is the continued commercialization of our Urgent® PC Neuromodulation System, the only FDA-cleared neuromodulation system that delivers posterior tibial nerve stimulation (PTNS) for the office-based treatment of overactive bladder and associated symptoms of urgency, frequency and urge incontinence. We also offer Macroplastique® Implants, an injectable urethral bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. For more information on the company and its products, please visit Uroplasty, Inc. at www.uroplasty.com.

SOURCE Uroplasty, Inc.