First microwave device to treat enlarged prostate - Food and Drug Administration approves Prostatron - Brief Article

FDA Consumer, July-August, 1996

The first medical device to treat symptoms of enlarged prostate with microwaves has been approved by FDA, providing an alternative to treatment with drugs or surgery.

Affecting more than half of men 60 and older, enlarged prostate (benign prostatic hyperplasia) causes a gradual increase in frequent, difficult urination, sometimes leading to urinary tract damage. Drug treatment gives only modest relief. Surgery is most effective but requires anesthesia and may result in blood loss, impotence, or other complications.

The new device, the Prostatron, heats and destroys excess prostate tissue with microwaves aimed by a computer system. Treatment is limited to medium-sized prostate glands. It takes one hour and can be done on an outpatient basis with local anesthetic. It has no significant effect on sexual function. However, it does not correct incomplete bladder emptying or weak urinary stream.

The Gastroenterology and Urology Devices Panel of FDA's Medical Devices Advisory Committee recommended approval last October. FDA approved the Prostatron May 6.

During testing of the device on 375 men over 45 at seven medical centers in the United States and Europe, 75 percent of patients had improved urinary symptoms-urgency, frequency, straining, or intermittent flow. Follow-up four years later found the improvement continued in about half, while the rest needed re-treatment with the device, or drugs or surgery, some time during those four years.

FDA requires the manufacturer, EDAP Technomed Group, of Cambridge, Mass., to study the device another year to assess its long-term effects and the need for re-treatment. The results will also be used to compare the Prostatron with other treatments.