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OrBIT Study Long Term Results Show Sustained Therapeutic Effect of Percutaneous Tibial Nerve Stimulation at 12 Months
Date:12/10/2009

MINNEAPOLIS, Dec. 10 /PRNewswire-FirstCall/ -- Uroplasty, Inc. (NYSE Amex: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today 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-t
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SOURCE Uroplasty, Inc.
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