Men coping with enlarged prostate problems and the threat of more serious urinary complications received reassurance about a convenient and less costly treatment alternative in a newly reported, carefully controlled clinical study published in the June issue of the Journal of Urology.
Comparing five-year results of Medtronic TUNA® Therapy (transurethral needle ablation) to surgery for 121 men in their mid-60s with lower urinary tract symptoms caused by an enlarged prostate, a team of urologists headed by Michael Naslund, M.D., professor of urology, University of Maryland School of Medicine, Baltimore, Maryland, found that “for appropriately selected patients with bothersome voiding symptoms, TUNA is an attractive treatment option.”
The team of urologists sought to determine if the long-term efficacy of tissue ablation with radiofrequency energy (as in TUNA Therapy) and its lower incidence of side effects make it a worthy challenger to surgical tissue removal, (TURP), the existing “gold standard” by which newer procedures are measured. They concluded that it does, even though they used older generations of Medtronic TUNA instrumentation that have now been succeeded by the fourth generation Medtronic Precision Plus™ TUNA system introduced in April, 2003. The later version adds computerized control, facilitates physician visualization during the procedure and reduces the procedure time significantly from earlier generations.
Patients participating in the prospective, randomized study at seven major U.S. medical centers were selected for TUNA Therapy or transurethral surgical resection of the prostate (TURP) and then evaluated at regular intervals for five years. After that time, more than half of the patients treated with the two procedures showed improvement in symptoms of at least 30 percent. Similarly, most also said their quality of life had improved by at least the same amount.
But while the patients who had obstructive tissue surgically removed with TURP showed slightly better results on tests for peak urinary flow and post-void residual urine, 41 percent reported retrograde ejaculation, in which a sphincter malfunction causes semen to travel into the bladder. The TUNA Therapy group reported none. The incidence of erectile dysfunction, incontinence and stricture formation was also greater in men who underwent the surgical procedure.
Nine of the 65 men in the TUNA Therapy group required further intervention for benign prostate enlargement problems and went on to surgery. One of the patients in the surgical study group underwent additional transurethral surgery, another received cancer treatment involving removal of the prostate.
The prostate gland surrounds the urethra and, as proliferating cells cause the gland to enlarge with age, it squeezes the urethra and restricts urine flow. The resulting benign prostatic hyperplasia (BPH) creates significant lifestyle issues, the researchers said, and the resulting lower urinary tract symptoms “if left untreated can lead to serious complications such as acute urinary retention, recurrent urinary tract infections and bladder calculi.”
BPH affects an estimated 23 million men worldwide with discomfort, inconvenience, interrupted sleep and embarrassment associated with the frequent and sudden need to urinate. According to the American Urological Association, 50 percent of men older than 50 and 80 percent of men older than 80 experience the symptoms. Until the U.S. introduction of TUNA Therapy in 1996, treatment options were limited to a lifetime of daily medications and their accompanying side effects, or TURP surgery that has a higher incidence of adverse effects including impotence, incontinence and retrograde ejaculation.
TUNA Therapy (an office-based procedure) delivers low-level radio frequency energy through a cystoscope inserted into the urethra to destroy obstructive tissue while protecting the urethra and adjacent structures from damage. After administration of local anesthesia, average treatment time is 15 minutes. Alternatively, TURP is a surgical procedure, requiring spinal or general anesthesia that must be performed in the hospital in which a resectoscope is inserted into the urethra and enlarged tissues are cut away using an electrical loop.
Medtronic TUNA Therapy received marketing clearance from the U.S. Food and Drug Administration in 1996 for the treatment of symptoms of BPH in men over the age of 50 with prostate sizes between 20cc and 50cc. More than 45,000 patients have been treated worldwide since approval. Medicare approved the procedure for in-office reimbursement on Jan. 1, 2000. Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. More information about Medtronic Urology is available online at www.medtronic-urology.com.