May 7, 1996 in Nation/World

Fda Approves Microwave Prostate Therapy Millions Of Men Now May Choose Prostatron Over Drugs Or Surgery

Lauran Neergaard Associated Press

Millions of men who suffer enlarged prostates now can choose a one-hour treatment over drugs or surgery: a machine that literally microwaves the prostate to relieve urinary symptoms.

The U.S. Food and Drug Administration approved the Prostatron, which kills excess prostate tissue by heating the gland with microwaves, based on studies showing the device may help 75 percent of patients.

“While not a cure, it effectively treats the symptoms” of enlarged prostates, FDA Commissioner David Kessler said Monday.

The Prostatron is a one-hour out-patient procedure that appears to work better than drugs and clearly is safer than surgery, said Dr. John Lynch, urology chief at Georgetown University Medical Center.

“It’s not 100 percent” effective, Lynch said, but “it is going to appeal to a broad spectrum of men … who have troublesome symptoms of this disease.”

The prostate is a walnut-sized gland that surrounds the urethra, which carries urine to the penis. Prostates enlarge as men age, squeezing the urethra and making it difficult to urinate. More than half of all men over age 60 have the problem, called benign prostatic hyperplasia, or BPH and 80 percent of men get it by age 80.

Surgery to trim the prostate is the most common and most effective treatment. But the $8,000 to $12,000 operation usually requires up to three days in the hospital and can cause complications such as impotence or incontinence.

There are two drugs approved to shrink the prostate or relax its hold, but they offer only modest relief and cost hundreds of dollars a year.

With the Prostatron, a catheter is threaded through the urethra into the prostate. A computer pulses microwaves through the catheter, heating the prostate to at least 111 degrees Fahrenheit, killing prostate tissue and clearing room for the urethra to function better.

Cooling water circulates inside the catheter so the urethra is not burned - and so patients don’t feel heat.

The Prostatron, performed under local anesthetic, treats most symptoms effectively, with no significant effect on sexual function, the FDA said.

In a test of 375 men over age 45, 75 percent saw improvement in such symptoms as frequent urination, awaking during the night to urinate, and control over urination.

The Prostatron’s one significant side effect was swelling in a third of men that left them temporarily unable to urinate. Catheters drained their urine during that time.

The Cambridge, Mass., manufacturer, EDAP Technomed Inc., has said Prostatron treatment could cost patients about half as much as surgery, but officials didn’t give an exact price Monday.

It takes six weeks to three months for patients to feel the full benefits of the Prostatron, Lynch said. In studies, half of patients felt the benefits lasted four years, but EDAP will study the Prostatron’s long-term effects to determine how many men need retreatment.

The Prostatron should be used only on medium-sized prostates, not very large ones, and does not correct all BPH symptoms, the FDA warned. For example, it had little effect on incomplete emptying of the bladder, a symptom Lynch called minor but that could affect which men are given the heat treatment over other alternatives.

Meanwhile, a study of the two main drugs used to relieve urine flow blockage among men with enlarged prostates found a combination of the two worked best.

The research compared the drugs finasteride, terazosin, a combination, or a placebo.

The combination scored best when measured on the American Urological Association’s symptom scale, which measures the amount of relief reported by patients, said the study’s director, Dr. Herbert Lepor of New York University School of Medicine. Terazosin by itself scored better than finasteride by itself.

Merck & Co., which markets finasteride under the brand name Proscar, attacked the study, saying the true measure should be the drug’s effect on shrinking the prostate.

Finasteride causes the prostate to shrink, while terazosin improves urine flow by relaxing muscles. Terazosin is marketed by Abbott Laboratories under the name Hytrim.

xxxx ENLARGED PROSTATES More than half of all men over age 60 have the problem, called benign prostatic hyperplasia, or and 80 percent of men get it by age 80.

WHERE TO FIND HELP Manufacturer EDAP Technomed Inc. said the treatment is available immediately at hospitals that tested it: Georgetown, Rush Presbyterian Hospital in Chicago, Kidney Stone Center in Denver and the Mayo Clinics in Rochester, Minn., and Jacksonville, Fla. The Prostatron went on sale to other hospitals on Monday.

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