OrBIT Study Long Term Results Show Sustained Therapeutic Effect Of Percutaneous Tibial Nerve Stimulation At 12 Months
October 17, 2017
Uroplasty, Inc. (NYSE Amex: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, highlighted the 12-month results of the OrBIT Trial of its Urgent® PC Neuromodulation System that will be published in the January 2010 print edition of THE JOURNAL OF UROLOGY®. The Urgent PC System is a proprietary, minimally invasive, percutaneous tibial nerve stimulation (PTNS) device designed for office-based treatment of urinary urgency, urinary frequency and urge incontinence, symptoms often associated with overactive bladder (OAB).
The long-term phase of the OrBIT Trial reported on 25 patients who had significant symptom improvement in the initial 12-week phase of the OrBIT Trial and continued PTNS therapy at increasing time intervals between treatments over a 12-month period.
Highlights from the study include:
-- 96% of PTNS patients considered their urinary symptoms cured or improved at 12 months
-- Investigators also considered 96% of PTNS patients cured or improved at 12 months
-- At 12 months statistically significant changes compared to baseline included:
-- Decrease in voiding episodes by 2.8 voids/day
-- Decrease in urge incontinence episodes by 1.6/day
-- Decrease in nighttime voids by 0.8/night
-- Increase in voided volume of 39 cc
-- PTNS patients also reported significant quality of life improvements
-- No serious adverse events were reported
-- From the 12-week visit through the 12-month visit, average interval between treatments was 21 days
"The durability of response demonstrates the effectiveness of percutaneous tibial nerve stimulation and strongly supports PTNS as a viable, long-term therapy for overactive bladder" said Dr. Scott MacDiarmid, the primary author, and Director of the Bladder Control and Pelvic Pain Center at Alliance Urology Specialists, Greensboro, NC. "PTNS represents an important addition to our therapeutic armamentarium. This study data is very exciting because the results mirror what we have observed in our clinical practice over the last three years."
Publication of the 12-month results follows that of the 12-week OrBIT (Overactive Bladder Innovative Therapy) multi-center trial in THE JOURNAL OF UROLOGY, September, 2009. The 12-week results demonstrated that patients treated with PTNS had clinical improvement comparable to patients treated with an oral extended release OAB drug with fewer significant side effects.
"These results confirm that PTNS sustains the therapeutic effect that patients experienced during the initial 12-week study," said Dave Kaysen, President and Chief Executive Officer of Uroplasty, Inc. "The investigators' assessments mirrored that of the patients which demonstrates both objective and subjective measures improved. Urgent PC is an effective and viable option for treating urinary symptoms often associated with overactive bladder. We will use these results to continue to educate medical directors about PTNS effectiveness to establish reimbursement. This study is also part of the clinical data that has been presented to the American Medical Association as part of our application for a unique CPT code for PTNS" added Mr. Kaysen.
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® Implants, an injectable urethral bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency.
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.
Source: Uroplasty, Inc