New Study Of Percutaneous Tibial Nerve Stimulation vs. Placebo Reinforces Evidence of Effectiveness
MINNEAPOLIS, Sept. 23 /PRNewswire/ — Uroplasty, Inc. (Nasdaq: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today highlighted results of a study “Percutaneous Tibial Nerve Stimulation Effects on Detrusor Overactivity Incontinence Are Not Due to a Placebo Effect: A Randomized, Double-Blind, Placebo Controlled Trial,” to be published in the November 2010 print edition of THE JOURNAL OF UROLOGYÃ‚®.
The Urgent PC Neuromodulation System is a proprietary minimally invasive, percutaneous tibial nerve stimulation (PTNS) device for office-based treatment of urinary urgency, urinary frequency and urge incontinence, symptoms often associated with overactive bladder (OAB).
This placebo-controlled, randomized, double-blind study was powered to show effectiveness with a sample size of 35 female patients. Patients and investigators reported statistically significant OAB symptom improvement in the PTNS group compared to the placebo group.
Highlights from the study include:
- 71% of the PTNS group reported a 50% or greater reduction in incontinence episodes, compared to a 0% reduction in the placebo group
- Statistically significant decrease in incontinence episodes in the PTNS group from 4.1 to 1.8 (p<0.001), compared to the placebo group which did not show a significant decrease
- Statistically significant decrease in voiding frequency in the PTNS group from 13.6 to 9.5 (p<0.001), compared to the placebo group which did not show a significant decrease
- Statistically significant increase in voided volume in the PTNS group from 150.5 cc to 186.5 cc (p<0.001), compared to the placebo group which did not show a significant increase
- After the third treatment, subjects were unable to identify whether they were receiving the PTNS therapy or the placebo, confirming that the placebo effectively mimicked the active treatment
- Neither group reported any serious adverse events
“We are very pleased with the outcome of this study and we believe it shows PTNS to be an effective treatment option for detrusor overactivity incontinence, and that a placebo effect seems to be negligible in this patient population,” said Dr. Enrico Finazzi-Agro, lead investigator, from the Department of Urology, University of Rome “Tor Vergata.” “Our study results confirm those of Dr. Peters et al from the recently published SUMiT study showing that PTNS is effective and safe for treating patients with detrusor overactivity as seen in overactive bladder.”
Dr. Ragi Doggweiler of the University of Tennessee Medical Center, provided editorial comment in the same edition titled: Will Posterior Tibial Nerve Stimulation Replace Sacral Nerve Root Stimulation as the Salvage Management of Drug Resistant Urinary Urge Incontinence?
“It is exciting to see that more functional approaches are being developed to treat voiding dysfunction,” Dr. Doggweiler said. “When reviewing the options available today, it makes sense to consider PTNS as a replacement for pharmacotherapy in patients on multiple medications. In addition, given the economic implications in today’s healthcare environment, PTNS may be considered as the first choice for neuromodulation over the more expensive and invasive sacral nerve stimulation,” added Dr. Doggweiler.
“We believe these results mirror those already reported from the SUMiT study,” said Dave Kaysen, President and Chief Executive Officer of Uroplasty, Inc. “Placebo controlled studies are standard in the pharmaceutical industry but rarely seen with medical devices. This study further reinforces the clinical efficacy of PTNS in the treatment of OAB and provides clinicians with another effective therapy for this often difficult-to-treat patient population,” added Mr. Kaysen.
For more information about the UrgentÃ‚® 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 MacroplastiqueÃ‚® 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.
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.
For Further Information:
Uroplasty, Inc. EVC Group David Kaysen, President and CEO, or Doug Sherk (Investors) Medi Jiwani, Vice President, CFO, and Treasurer, 415.896.6820 952.426.6140 Chris Gale (Media) ------------ 646.201.5431 ------------
SOURCE Uroplasty, Inc.