MINNEAPOLIS, May 21 Uroplasty, Inc. (Amex: UPI),a medical device company that develops, manufactures and markets innovativeproprietary products for the treatment of voiding dysfunction, todayhighlighted results from the OrBIT trial of its Urgent(R) PC System. TheUrgent PC System is a proprietary, minimally invasive percutaneous tibialnerve stimulation (PTNS) device designed for office-based treatment of urinaryurgency, urinary frequency and urge incontinence, symptoms often associatedwith overactive bladder (OAB). Dr. Kenneth M. Peters, Chairman of theDepartment of Urology at Beaumont Hospital in Royal Oak, Michigan, leads theOrBIT (OveRactive Bladder Innovative Therapy) multi-center trial and presentedthe comparative study's results today at the 2008 American UrologicalAssociation (AUA) Annual Meeting, being held in Orlando, Florida.
The results confirm that Urgent PC's PTNS reduces the incidence of voidingepisodes at a rate comparable to tolterodine LA, known by the trade nameDetrol(R) LA (Pfizer), the leading pharmaceutical therapy for OAB. Highlightsfrom the study include:
"PTNS provides comparable effectiveness to pharmaceuticals and may beconsidered an alternative to pharmacologic therapy for the treatment of OAB,"Dr. Peters concluded.
In an oral presentation, "A Randomized Multi-center Study ComparingPercutaneous Tibial Nerve Stimulation with Pharmaceutical Therapy for theTreatment of Overactive Bladder," Dr. Peters presented results from a study of100 patients conducted in 11 U.S. centers. These patients were randomized toeither PTNS treatment with the Urgent PC, or to tolterodine LA. All patientsin the study were diagnosed with urinary frequency at eight or more voids perday. Patients randomized into the PTNS treatment were treated weekly for 12consecutive weeks, while patients randomized into the pharmacologic therapywere given a 90-day prescription for 4 mg daily. All patients completedvoiding and bladder control diaries and questionnaires at baseline and aftertheir 12-week follow-up.
"These results demonstrate that the Urgent PC is an effective and viablenon-drug option for treating the urinary symptoms often associated withoveractive bladder," said Dave Kaysen, President and Chief Executive Officerof Uroplasty, Inc. "Leading urologists across the country have been addingPTNS to their armamentarium for OAB treatment, reporting excellent outcomesand high patient satisfaction. We are delighted to have the OrBIT resultsvalidate Urgent PC's effectiveness compared to drugs and minimal side effectsand expect that adoption will continue to improve, especially as additionalclinical evidence emerges."
For more information about the Urgent(R) PC Neuromodulation System, pleasecall 866-277-0466 or visit http://www.uroplasty.com.
About the Urgent PC Neuromodulation System
The Urgent PC neuromodulation system is a proprietary, minimally invasivenerve stimulation device designed for office-based treatment of urgeincontinence, urinary urgency and urinary frequency, symptoms often associatedwith overactive bladder. Application of neuromodulation therapy targetsspecific nerve tissue and disrupts the signals that lead to these symptoms.Uroplasty sells the Urgent PC system in the United States, Canada, andcountries recognizing the CE mark. Outside of the United States, Urgent PC isalso indicated for the treatment of fecal incontinence.
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly ownedsubsidiaries in The Netherlands and the United Kingdom, is a medical devicecompany that develops, manufactures and markets innovative proprietaryproducts for the treatment of voiding dysfunctions. Our primary focus is thecommercialization of our Urgent PC system, which we believe is the onlyFDA-approved non-surgical neurostimulation therapy for the treatment of