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With the OrBIT Trial featured on the cover of this month's JOURNAL OF UROLOGY, this marks the first publication of a study to compare a drug, considered a current standard of care, against Urgent PC PTNS in a randomized, controlled overactive bladder trial.
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Highlights from the study include:
"PTNS may be considered a clinically significant alternative to pharmacologic therapy for the treatment of OAB with statistically significant improvements in patient self-assessments compared to drugs, and comparable objective effectiveness," said Dr. Kenneth M. Peters, the primary author, and Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Michigan. "PTNS represents an important addition to our therapeutic armamentarium."
Dr. Peters led the 12-week OrBIT (Overactive Bladder Innovative Therapy) multi-center trial, on which the article "Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Extended-Release Tolterodine: Results From the Overactive Bladder Innovative Therapy Trial" is based.
The results confirm that Urgent PC's PTNS reduces the incidence of voiding episodes at a rate comparable to extended-release tolterodine, known by the trade name Detrol(R) LA (Pfizer), the leading pharmaceutical therapy for OAB, and that patients report a statistically significant decrease in their overall OAB symptoms compared to patients on extended-release tolterodine.
The study of 100 patients was conducted in 11 U.S. centers. These patients were randomized to either PTNS treatment with Urgent PC, or to extended-release tolterodine. All patients in the study were diagnosed with urinary frequency at eight or more voids per day. Patients randomized into the PTNS treatment were treated weekly for 12 consecutive weeks, while patients randomized into the pharmacologic therapy were given a 90-day prescription of 4 mg daily. All patients completed voiding and bladder control diaries and questionnaires at baseline and after completion of 12 weeks of treatment.
"The publishing of these results, which show strong efficacy compared to a leading pharmaceutical, adds to the ongoing accumulation of clinical evidence supporting Urgent PC as an effective and viable option for treating the urinary symptoms often associated with overactive bladder," said Dave Kaysen, President and Chief Executive Officer of Uroplasty, Inc. "We are presenting this OrBIT data - and the many other studies supporting Urgent PC's efficacy - to the medical directors of U.S. payers as part of our effort to build awareness for reimbursement and eventually apply for a unique CPT code for PTNS here in the U.S."
For more information about the Urgent(R) PC Neuromodulation System, please call 866-277-0466 or visit www.uroplasty.com.
About the Urgent PC Neuromodulation System
The Urgent PC neuromodulation system is a proprietary, minimally invasive nerve stimulation device designed for office-based treatment of urge incontinence, urinary urgency and urinary frequency, symptoms often associated with overactive bladder. Application of neuromodulation therapy targets specific nerve tissue and disrupts the signals that lead to these symptoms. Uroplasty sells the Urgent PC system in the United States, Canada, and countries recognizing the CE mark. Outside of the United States, Urgent PC is also indicated for the treatment of fecal 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 focus is the continued commercialization of our Urgent PC system, which we believe is the only FDA-approved minimally invasive nerve stimulation device designed for office-based treatment of urinary urgency, urinary frequency and urge incontinence, symptoms often associated with overactive bladder.
We also offer Macroplastique(R) 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.
Forward-Looking Information
This press release contains forward-looking statements, which 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. Further, we cannot assure you that we will timely obtain, or even succeed at all at obtaining, a unique CPT reimbursement code from the American Medical Association for Urgent PC treatments, that even if we obtain a unique CPT reimbursement code third-party payors will provide or continue to provide coverage and reimbursement, or reimburse the providers an amount sufficient to cover their costs and expenses.
-- 80% of PTNS patients considered their OAB symptoms cured or improved, while 55% of extended-release tolterodine patients considered themselves cured or improved. -- Physicians considered 80% of PTNS patients cured or improved, compared with 61% of extended-release tolterodine patients. -- The frequency of voiding episodes was reduced in 73% of PTNS patients versus 74% of extended-release tolterodine patients. -- 80% of PTNS patients had an improvement in urge incontinence compared to 73% of extended-release tolterodine patients. -- No serious adverse events were associated with either treatment and each group had similar low rates of treatment related events. Patients in the extended-release tolterodine group reported constipation and dry mouth more often than those in the PTNS group. -- Most patients were female with an average age of 58 years, and an average history of OAB duration of more than 9 years.
SOURCE Uroplasty, Inc.
