Shands Hospital at UF Is One Of Six FDA-Approved Sites For New Prostate Procedure

May 3, 1996

ORLANDO—Millions of older men who develop enlarged prostate glands can now choose an alternative to surgical procedures that require general anesthesia and often cause uncomfortable side effects.

The new procedure, known as TransUrethral Needle Ablation (TUNA), takes less than 40 minutes and is performed on an outpatient basis using a local anesthetic. It causes less irritation and patients can return to their regular activities the same day.

University of Florida urologists will perform the procedure on two men at Shands Hospital at UF during a live video satellite transmission to be aired at today’s (5/3) annual meeting of the American Urological Association in Orlando. The procedure will be performed during a continuing education course for physicians.

One patient, 60, is from Ocala, while the other is a 67-year-old dentist who has come from the U.S. Virgin Islands. They will be the fourth and fifth people to undergo TUNA at Shands, but physicians expect the procedure to become commonplace. Shands is one of six U.S. sites approved by the federal Food and Drug Administration to offer the treatment.

The prostate gland, about the size of a walnut, is found just below the bladder and usually begins to enlarge when men are in their 40s. In benign prostatic hyperplasia, nodules grow around the tube-like urethra that empties the bladder and passes through the center of the prostate. The nodules compress the urethra and obstruct the flow of urine, causing discomfort and heightening the risk of infection.

One in four men older than 50 will seek treatment for an enlarged prostate by the time they reach age 80, said Dr. Perinchery Narayan, professor and chief of urology at UF’s College of Medicine. Of the estimated 7.2 million U.S. men who are in that age range, 1 to 2 million are being treated with medications, while nearly 300,000 are operated on each year.

During the TUNA procedure, a small catheter containing sheathed needles is inserted into the urethra. The needles are unsheathed and low levels of radiofrequency energy heat the tissue that is obstructing the flow of urine, thereby shrinking the swollen gland.

The technology for the TUNA procedure was developed by Vidamed, a California-based medical technologies company, which also funded early research, comparing it with traditional techniques at UF and five other U.S. medical centers.

Traditional methods involve cutting away the tissue. Surgery is performed under general or spinal anesthesia and requires partial removal of the gland. Using a lighted scope inserted through the urethra, surgeons “core out” the middle section of the prostate. Though effective in reducing the size of the gland, the technique may cause complications such as incontinence or bleeding, requiring transfusions.

“The disadvantage of this surgery is that it may cause bleeding that is difficult to stop,” Narayan said. “A certain percentage of patients who have bleeding experience some complications, including occasional accidental injury to the areas near the prostate, such as the urethral and sphincter mechanisms regulating the control of urine.”

Patients also have some post-operative restrictions, he added, such as not being able to lift heavy objects, and having to restrain activity for few weeks. The surgery also cannot be performed on patients who are taking blood-thinners or aspirin, because of the risk of bleeding.

Walter Copeland III, 60, of Madison, underwent the TUNA procedure April 9, and was able to return to his normal routine soon afterward.

“They did a procedure to shrink the prostate, rather than to cut and remove it,” Copeland said. “And if the procedure wasn’t successful, I wouldn’t have burned my bridges. I could still go back and have the traditional surgery. I thought it was worth trying because it was less invasive, and it was done under local anesthesia. It was not terribly uncomfortable. I was aware of a slight pinching but it was nothing unbearable.”

Narayan is at the forefront in the study of several techniques that predate TUNA, including laser treatment and a procedure known as electrovaporization. Both use heat to vaporize tissue and minimize bleeding. But, unlike TUNA, they typically require spinal anesthesia and are more irritative to the lining of the prostate. Many patients report temporary side effects, such as a burning sensation when urinating, or an increase in frequency.

UF researchers published their findings from the largest study yet of men undergoing the electrovaporization procedure in the April issue of the journal, Urology. That trial, which did not incorporate a study of TUNA, found electrovaporization does have significant advantages over traditional surgery to partially remove the prostate.