Uroplasty, Inc. (Amex: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today highlighted results published in the September, 2009 edition of THE JOURNAL OF UROLOGY(R) from the OrBIT trial of its Urgent PC System. 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).
With the OrBIT Trial featured on the cover of this month's JOURNAL OF UROLOGY, this marks the first publication of a study to compare a drug, considered a current standard of care, against Urgent PC PTNS in a randomized, controlled overactive bladder trial.
Highlights from the study include:
- 80% of PTNS patients considered their OAB symptoms cured or improved, while 55% of extended-release tolterodine patients considered themselves cured or improved.
- Physicians considered 80% of PTNS patients cured or improved, compared with 61% of extended-release tolterodine patients.
- The frequency of voiding episodes was reduced in 73% of PTNS patients versus 74% of extended-release tolterodine patients.
- 80% of PTNS patients had an improvement in urge incontinence compared to 73% of extended-release tolterodine patients.
- No serious adverse events were associated with either treatment and each group had similar low rates of treatment related events. Patients in the extended-release tolterodine group reported constipation and dry mouth more often than those in the PTNS group.
- Most patients were female with an average age of 58 years, and an average history of OAB duration of more than 9 years.
"PTNS may be considered a clinically significant alternative to pharmacologic therapy for the treatment of OAB with statistically significant improvements in patient self-assessments compared to drugs, and comparable objective effectiveness," said Dr. Kenneth M. Peters, the primary author, and Chairman of the Department of Urology at Beaumont Hospital in Royal Oak, Michigan. "PTNS represents an important addition to our therapeutic armamentarium."
Dr. Peters led the 12-week OrBIT (Overactive Bladder Innovative Therapy) multi-center trial, on which the article "Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Extended-Release Tolterodine: Results From the Overactive Bladder Innovative Therapy Trial" is based.
The results confirm that Urgent PC's PTNS reduces the incidence of voiding episodes at a rate comparable to extended-release tolterodine, known by the trade name Detrol(R) LA (Pfizer), the leading pharmaceutical therapy for OAB, and that patients report a statistically significant decrease in their overall OAB symptoms compared to patients on extended-release tolterodine.
The study of 100 patients was conducted in 11 U.S. centers. These patients were randomized to either PTNS treatment with Urgent PC, or to extended-release tolterodine. All patients in the study were diagnosed with urinary frequency at eight or more voids per day. Patients randomized into the PTNS treatment were treated weekly for 12 consecutive weeks, while patients randomized into the pharmacologic therapy were given a 90-day prescription of 4 mg daily. All patients completed voiding and bladder control diaries and questionnaires at baseline and after completion of 12 weeks of treatment.
"The publishing of these results, which show strong efficacy compared to a leading pharmaceutical, adds to the ongoing accumulation of clinical evidence supporting Urgent PC as an effective and viable option for treating the urinary symptoms often associated with overactive bladder," said Dave Kaysen, President and Chief Executive Officer of Uroplasty, Inc. "We are presenting this OrBIT data - and the many other studies supporting Urgent PC's efficacy - to the medical directors of U.S. payers as part of our effort to build awareness for reimbursement and eventually apply for a unique CPT code for PTNS here in the U.S."