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July 31, 2006
Urodynamix Reports Successful Results for NIRS in Stress Urinary Incontinence and Over Active Bladder in Women
For Immediate Release:
Vancouver, BC - (July 31, 2006) Urodynamix Technologies Ltd. (TSX.V: URO) announced today successful clinical test results for it’s near infrared spectroscopy (NIRS) technology for the evaluation of Stress Urinary Incontinence (SUI) and Overactive Bladder (OAB) in women (SUI & OAB Study).
The SUI & OAB Study showed that in all patients (n=24) with SUI and OAB (“Positive” patients), the Company’s non-invasive NIRS technology accurately measured and identified bladder conditions when to compared to diagnosis by existing invasive catheter based systems.
“In this study, NIRS was able to determine differences between normal female subjects and female subjects who presented with Stress Urinary Incontinence and/or Overactive Bladder. NIRS offered reliable information in a non-invasive and simple procedure that currently is not available in the clinical setting. Based on the data, we believe NIRS will significantly impact the clinical diagnosis and study in the diagnosis of women with lower urinary tract symptoms,” stated Dr. Lynn Stothers, Principal Investigator, Professor and Director of UBC Bladder Care Centre.
This clinical study, supported in part by the Canadian Institutes of Health Research (“CIHR Study”), was conducted by Drs. Lynn Stothers and Andrew Macnab from Feb 1, 2006 to May 30, 2006 at UBC Hospital Bladder Care Centre. (See also July 5, 2006 Press Release.) In this study, patients were intentionally recruited for a focused study of SUI and OAB. Seventy-three subjects were enrolled in the CIHR Study, including 16 Positive SUI female subjects (one was excluded) and 8 Positive OAB female subjects. A total of 12 “Normal” females were enrolled. In this population, Positive subjects underwent simultaneous NIRS urodynamic and catheter based urodynamic procedures while Normal subjects underwent Uroflow and NIRS urodynamics.
The SUI & OAB Study showed that NIRS oxygenated hemoglobin (Hb02), deoxygenated hemoglobin (Hb), and cytochromes (Cyt) parameters provide measurable and significant clinical data during the urodynamic procedure for subjects previously diagnosed with OAB and SUI. The study concluded that NIRS provided quantifiable evidence of OAB and SUI in this study population. Furthermore, NIRS offered this reliable information in a non-invasive and simple procedure that is not currently available.
In addition, the study showed statistically significant differences in measured changes in Hb02, Hb, and Cyt for Positive versus Normal subjects. For OAB vs. Normal, absolute changes in concentrations over the filling period yield areas under ROC curves (AUC) of 0.80, 0.85 and 0.88 respectively for HbO2, Hb, and Cyt. For SUI vs. Normal, absolute changes in concentrations over the filling period yield AUC of 0.75, 0.81 and 0.83 respectively for HbO2, Hb, and Cyt. ROC, or receiver operating characteristic, is a standard statistical analysis apparatus indicating the relationship between the true positive rate and the false positive rate where 1.0 is considered a perfect diagnostic test.
Barry Allen, President and Chief Executive Officer, added, "This second study clearly shows the power of our NIRS technology in the approximately 40 million women and 9.5 million men suffering from OAB and SUI in North America. We are impressed with the data and are confident that additional pending studies with our new prototype will confirm or improve on these positive results. We have now shown performance of our device in both men and women, and in the three leading causes of UI worldwide."
About Stress Incontinence:
Stress urinary incontinence (SUI) is the most common type of urinary incontinence in women. Symptoms of SUI include involuntarily leaking urine during coughing, sneezing, and physical activities such as jumping, heavy lifting, or sex. In severe SUI patients, simply standing up can cause leakage. SUI is caused by weakening of the pelvic floor muscles and or damage to the nerves that control the urinary sphincter such as vaginal childbirth, hysterectomy, pregnancy, menopause, chronic cough, obesity, and pelvic organ prolapse. When these symptoms are brought to the attention of a physician, tests such as urinanalysis, urodynamics, or urinary stress test are used to determine the correct diagnosis and treatment. Treatments can include kegel exercises, biofeedback, electrical stimulation, medications, and in some cases, surgery.
According to the National Association For Continence (NAFC), SUI symptoms affect an estimated 34 million women in the United States today and women make up over 90% of the SUI population. Most women affected by SUI fall between the ages of 35 and 60.
About Overactive Bladder:
Overactive bladder (OAB) disrupts millions of people’s lives, however, it is treatable and not a natural part of aging. OAB occurs when the smooth muscle of the bladder (the detrusor muscle) contracts without warning, typically when the bladder is not full. OAB symptoms include frequent urination, urgency of urination, urge incontinence (involuntary loss of urine), and nocturia (night-time urination). Any combination of these symptoms can occur with urge incontinence (wet OAB) or without urge incontinence (dry OAB). These symptoms may cause significant social, psychological, occupational, domestic, physical, and sexual problems. Certain drugs, nerve damage, stroke, neurological disease, or bladder stones can cause OAB. When these symptoms are brought to the attention of a physician, assessment options include a bladder diary, urinalysis, uroflowmetry, post-void residual volume test, urodynamic study, stress test, and cystoscopy. OAB treatment options include medications, pelvic muscle rehabilitation, behavioural therapies, neuromodulation and surgery.
OAB affects more than 17 million men and women in the United States with the condition being almost equally split between men and women. In 2000, the estimated cost related to overactive bladder in the United States was nearly $14B.
A detailed summary of the results is available by contacting Dr. Luya Li, VP Technology, Urodynamix at lli@urodynamix.com.
About Urodynamix Technologies Ltd.
Urodynamix Technologies Ltd. is the world leader in non-invasive measurement of bladder function and urological conditions. Urodynamix is focused on the development and commercialization of breakthrough diagnostic technology for bladder conditions specifically urinary incontinence (UI). Urodynamix is currently developing a family of non-invasive diagnostic and monitoring technologies for the over 200 Million UI sufferers worldwide.
On behalf of the Board,
“Barry Allen”
President & CEO
Urodynamix Technologies Ltd.
Certain information contained in this press release may be forward looking and is subject to unknown risks, which could cause actual results to differ materially from those, set forth or implied herein.Al though the Company believes that the expectations reflected in such forward-looking statements are reasonable; it can give no assurance that such expectations will prove correct.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
For further information, please contact:
Barry Allen
Email: ballen@urodynamix.com |
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