Heat therapy may reduce prostate surgery
Heat therapy may reduce prostate surgery
A new heat therapy for treating benign prostatic hyperplasia could significantly reduce the need for surgery for men who suffer from noncancerous enlargement of the prostate, according to a leading urologist who conducted clinical trials of the therapy.
The Prostatron, a device developed by EDAP Technomed of Cambridge, MA, uses microwave energy to destroy excess prostate cells. Until the device received approval in May from the Rockville, MD-based Food and Drug Administration, the condition could be treated with medication, or transurethral resection of the prostate (TURP), or transurethral incision of the prostate, which is an outpatient procedure.
"We had a sustained improvement in the patients’ symptoms and urinary flow rates [with the Prostatron]," says James B. Regan, MD, associate professor of surgery in the Division of Urology at Georgetown University Medical Center in Washington, DC. "In some regard, it was better than medical therapy."
At least 50% of all men over the age of 60 suffer from benign prostatic hyperplasia, according to EDAP Technomed. The condition causes prostate cells to grow, enlarging the gland and pressing against the urethra. The symptoms include difficult, frequent, or urgent urination.
With "thermotherapy" produced by the Prostatron, a catheter with a tiny internal antenna is inserted into the urethra. The antenna emits microwave heat that destroys prostate tissue, resulting in relief of the patient’s urinary symptoms, says Regan, who was a lead clinical investigator of the device. The heating takes one hour, requires no anesthesia, and can be performed in a physician’s office.
"The advantage of this over traditional therapies is there’s no cutting of tissue, no anesthesia, and no hospitalization required," he says. TURP requires general anesthesia and can involve a hospital stay of as long as three days.
Regan notes that surgery will remain "the gold standard" for treatment of benign prostatic hyperplasia because it has a higher success rate. For example, in cases in which the median lobe and the lateral lobes of the prostate are growing into the urethra, thermotherapy would not be indicated, he says. It also cannot be used on men who have a pacemaker or metallic implants.
Still, "the majority of men who have symptomatic enlargement would be candidates," Regan says, adding that it could "significantly reduce the surgical option." Neither Regan nor a spokesperson for EDAP Technomed could estimate how many patients are likely to pursue the thermotherapy treatment, which the company has dubbed Transurethral Microwave Therapy (TUMT).
Reimbursement for the procedure also has not been determined, although EDAP Technomed estimates that the procedure will cost half of that of TURP. Medicare, a primary payer for this group of patients, has not yet set a rate, Regan says.
Patients can resume normal activities immediately after the thermotherapy procedure, and four follow-up visits are recommended, says EDAP Technomed marketing manager Elizabeth DiNolfo. Some patients need a catheter for a few days following the procedure to aid in urination, but the therapy is not associated with any major complications, according to company material.
The Prostatron costs $395,000, or the company can arrange a lease, DiNolfo says.
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