Results from a Phase I human study of a new treatment option for benign prostatic hyperplasia (BPH) helps men overcome problems associated with an enlarged prostate gland without the need for surgery.
BPH accounts for a variety of urinary difficulties in men over the age of 50. These symptoms typically include a need to pass urine more frequently (especially at night), an urgent need to urinate, weak or interrupted urine flow, a feeling that the bladder is not completely empty, and a delay or hesitation at the onset of urination. It is estimated that 50 percent of men over age 50 suffer from BPH.
Produced by Celsion Corporation, this exciting new therapy uses two mechanisms to overcome the problem of an enlarged prostate. First, a microwave balloon catheter system shrinks the prostate through the delivery of microwave heating. Second, simultaneous expansion of the balloon catheter compresses the walls of the urethra, enlarging the urinary opening.
Since the system is designed to relieve obstruction, it concomitantly relieves uncomfortable urinary symptoms. The procedure can be performed on a one-time, outpatient basis.
The results of the Phase I trial, conducted by researchers at the Montefiore Medical Center in New York, are reportedly encouraging. Principal investigator Dr. Arnold Melman stated that “(The) preliminary results suggest that the system, when fully tested and approved, could provide immediate symptomatic relief.” He added, “If Phase II studies are successful, I believe Celsion’s system should encourage a greater number of men with BPH to seek treatment, particularly those who suffer from milder forms of the condition.”
The company is in the midst of seeking approval from the U.S. Food and Drug Administration (FDA) for multi-site Phase II clinical studies. The studies are required to determine the safety and effectiveness of the system in benign prostatic hyperplasia patients. Pending FDA approval, Celsion plans to start Phase II studies in the summer of 1999. If the results obtained are positive, the company will then apply for premarket approval from the FDA to market the system in the United States.