Urodynamix Announces Positive Data From LUTS Pivotal Trial

Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Dec 2007 - 2:00 PDT

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Urodynamix Technologies Ltd. (TSX-V:URO) announced positive results from a pivotal clinical trial establishing the safety and efficacy of the Company's near infrared spectroscopy (NIRS) technology for the non-invasive diagnosis of male patients with lower urinary tract symptoms (LUTS).

The study was carried out by principal investigator Dr. Lynn Stothers, MD and co-principal investigator Dr. Andrew Macnab, MD at The University of British Columbia's Bladder Care Centre and enrolled 72 male subjects with LUTS. The results of the study confirmed that Urodynamix's non-invasive NIRS procedure, when used in conjunction with uroflowmetry and ultrasonic bladder volume measurement, accurately classified subjects as obstructed or unobstructed compared to the current 'gold standard' of catheter-based urodynamic testing (UDS).

"The study confirmed that a non-invasive evaluation of the bladder using NIRS and uroflow can diagnose outlet obstruction with efficacy comparable to current invasive urodynamic techniques, and with none of the discomfort or potential side effects of catheter-based procedures," said Barry Allen, President and CEO of Urodynamix. "The results are exciting because they demonstrate that NIRS may provide a non-invasive alternative for the diagnosis of high-risk patients and those who may wish to avoid invasive testing."

Of 72 subjects enrolled in the trial, 55 procedures met the inclusion criteria and were included in the data analysis. The study's primary objective was to determine whether NIRS data in conjunction with uroflowmetry (maximum flow rate, Qmax) and ultrasonic bladder volume measurement (post-void residual urine volume, or PVR) agreed with invasive UDS in more than 80% of cases. The study met both of its primary efficacy endpoints, with the NIRS + Qmax + PVR procedure correctly predicting obstructed (N = 24/28, sensitivity = 85.7%) and unobstructed (N = 24/27, specificity = 88.9%) classification compared to the investigator's diagnostic decision made with catheter-based UDS.

The trial results were included as part of the 510(k) pre-market notification submitted to the FDA by Laborie Medical Technologies for the Tetra(tm) Bladder Monitor System, which is based on Urodynamix's NIRS technology.

About LUTS

Lower urinary tract symptoms are common in middle-aged men and describe a range of urinary symptoms that may be linked with prostate disease or bladder dysfunction. The prevalence of LUTS is believed to be as high as 90% in men aged 50 to 80 years old.

LUTS are most often associated with an enlarged prostate; however symptoms alone cannot be used to make a diagnosis. Current diagnostic procedures rely upon the International Prostate Symptom Score questionnaire in combination with urinalysis, serum prostate-specific antigen (PSA) test and digital rectal examination. Invasive pressure-flow urodynamic studies currently offer the only way to differentiate between obstruction caused by enlarged prostate and bladder disease.

Accurate diagnosis is important to ensure appropriate treatment of the underlying disease. Therapies now available to treat LUTS related to prostate disease include open surgical procedures, transurethral surgical procedures, microwave therapy, and pharmacotherapies.

About Urodynamix Technologies Ltd.

Urodynamix Technologies is a Canadian medical device company that develops and commercializes non-invasive medical technology based on its proprietary near-infrared spectroscopy (NIRS) platform. The Company is currently focused on products to aid in the diagnosis and treatment of urinary incontinence, lower urinary tract symptoms, prostate cancer, benign prostatic hyperplasia, and traumatic increases in intra-abdominal pressure that cause abdominal compartment syndrome. Urodynamix's breakthrough medical technology has the potential to beneficially affect more than 200 million people worldwide.

Urodynamix Technologies Ltd.