ATLANTA, Ga. & SOLANA BEACH, Calif., April 30, 2000 (PRIMEZONE) --- Findings presented today at the 95th Annual American Urological Association Meeting show that a unique indwelling drug delivery device provides a way to continuously deliver drug solution directly to the bladder to treat incontinence.
Developed by Situs Corporation, the proprietary UROS(tm) Drug Delivery System utilizes the UROS Infusor, a unique, soft-balloon reservoir introduced into and removed from the bladder in an outpatient procedure. The Infusor is designed to deliver a continuous, predictable level of solution for up to several weeks.
The data presented by Rodney A. Appell, M.D., Head, Section of Voiding Dysfunction and Female Urology at the Cleveland Clinic Foundation, summarized the investigational work needed for FDA approval to conduct clinical studies to further evaluate the safety and efficacy of this new treatment modality. Following IND approval last year, clinical studies now are underway at multiple institutions, including Baylor College of Medicine in Houston, Texas, the site of the largest study, headed by Timothy Boone, M.D., Associate Professor, Scott Department of Urology.
Findings presented at the AUA meeting focused on two clinical studies involving a total of 16 women. In the first (randomized and blinded) study, 13 healthy females received saline via the UROS infusor for three days. Results showed they tolerated the device well and voided normally. In the second trial, three women suffering from overactive bladder were treated with oxybutynin solution using the infusor for 24 hours. Findings showed that two patients experienced a greater than 100% increase in bladder capacity and all three had acceptable tolerance levels and no side effects.
"These preliminary findings offer the promise of a new option for treatment of overactive bladder sufferers. Situs' novel delivery system may be an alternative for patients who can't be treated with conventional oral medication yet don't want to be resigned to adult diapers and pads to manage their condition," said Dr. Appell.
Overactive bladder is a chronic condition affecting up to 50 million individuals, including 17 million Americans. The condition is characterized by urgency, frequency, or urge incontinence and is most common among women and the elderly. The annual societal costs of urinary incontinence exceed $26 billion in the U.S. and are expected to increase significantly as the general population ages. Current therapies are largely limited to oral medications, which often have severe side effects causing more than 50% of patients to drop out of treatment.
Situs Corporation is a pioneer in intravesical drug delivery. The company's site-specific drug delivery platform is capable of administering various pharmaceutical compounds for the treatment of local and systemic conditions. Situs has received FDA approval for two Investigational New Drug (IND) applications, for both its proprietary intravesical solution, I-OXY(tm) and for the UROS System. Other potential applications of the UROS technology include chemotherapeutic agents for bladder cancer, hormones for genitourinary conditions and analgesics for pain. For more information, visit the company's Web site at www.situscorp.com.