Uroplasty Announces Enrollment of First Patients in the CONFIDeNT Clinical Study for Treatment of Fecal Incontinence with Urgent® PC
MINNEAPOLIS, Feb. 15, 2012 /PRNewswire/ — Uroplasty, Inc. (NASDAQ:UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today announced the first enrollment of patients in the CONFIDeNT clinical study in the United Kingdom.
This large multi-center, placebo-controlled study will enroll over 200 patients in up to 20 centers across the UK. Using Uroplasty’s minimally-invasive Urgent® PC Neuromodulation System, the study will compare percutaneous tibial nerve stimulation (PTNS) treatments to a sham device for patients suffering from fecal incontinence. Outside of the U.S., Urgent PC has a CE Mark for treating fecal incontinence. This is one of several studies currently being conducted throughout Europe to demonstrate the effectiveness of Urgent PC for treating this debilitating and often under-treated, under-reported condition.
“This new physician-initiated study in the UK is indicative of the interest in using Urgent PC to treat fecal incontinence,” said David B. Kaysen, President and CEO of Uroplasty, Inc. “The interest in PTNS treatments from internationally known researchers emphasizes the on-going need for effective therapies to treat this very difficult and challenging condition. For many patients, effective treatment for this oftentimes socially isolating condition may well transform their lives.”
The Chief Investigator of the CONFIDeNT study in the UK is Prof. C.H. Knowles, BChir, PhD, FRCS (Gen Surg), Professor of Surgical Research and Hon. Consultant, Colorectal Surgeon, Academic Surgical Unit, Centre for Digestive Diseases, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University, London. Prof. Knowles stated, “The CONFIDeNT study is a major effort to fully understand how PTNS using Urgent PC, a new and unique technology, can be used to treat patients suffering from this debilitating disease of fecal incontinence. In addition to Uroplasty’s support, we appreciate the grant support of the NHS and National Institute for Health Research (Health Technology Assessment programme) in the UK along with the clinicians associated with Enteric’s clinical network.”
In the UK, the National Institute of Health estimated in 2007 that 6% of the population under 40 years of age experienced a problem with fecal incontinence either daily or weekly. The rate was 15% in women and 6% to 10% in men over 40 living in the community (noninstitutionalized). In the U.S., a 2009 study estimated that 5% to 10% of the population experienced fecal incontinence, equating to approximately 15 to 30 million individuals affected in the US.
“Uroplasty is committed to actively work with the key researchers involved in Urgent PC research projects across Europe. It is premature to discuss the time frames for the completion of these studies because patient enrollment rates are difficult to predict. We may present additional information as study milestones are achieved,” Mr. Kaysen concluded.
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 Neuromodulation System, the only FDA-cleared neuromodulation system that delivers posterior tibial nerve stimulation (PTNS) for the office-based treatment of overactive bladder and associated symptoms of urgency, frequency and urge incontinence. 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. For more information on the company and its products, please visit Uroplasty, Inc. at www.uroplasty.com.
For Further Information: Uroplasty, Inc. EVC Group David Kaysen, President and CEO, or Doug Sherk/Jenifer Kirtland (Investors), 415.568.9349 Medi Jiwani, Vice President, CFO, Treasurer Chris Gale (Media), 646.201.5431 952.426.6140 ------------
SOURCE Uroplasty, Inc.