A new medical device offers an alternative to open surgery and drugs for the treatment of benign prostatic hyperplasia.

A new medical device offers a less invasive way to treat symptoms caused by an enlarged prostate.

This walnut-sized gland in men sits below the bladder and surrounds the urethra, the tube that carries urine from the bladder out of the body.

As a man ages, it is common for the prostate to grow, a condition called benign prostatic hyperplasia (BPH). This rarely causes symptoms before age 40, but in older men the growing prostate can press on the urethra and reduce or block the flow of urine.

The U.S. Food and Drug Administration (FDA) recently approved the marketing of the UroLift system, a permanent implant that has been shown to relieve symptoms of an enlarged prostate in men 50 years or older.

According to the National Institute of Diabetes and Digestive and Kidney Diseases, over half of men in their sixties and almost 90 percent of men in their seventies have some symptoms of BPH, which include:

  • more frequent urination, especially at night
  • weak, hesitant, or interrupted stream of urine
  • urgent need to urinate
  • leaking or dribbling during or after urination

Severe BPH can lead to the retention of urine and strain on the bladder. Left untreated, this can cause urinary tract infections, damage to the bladder or kidneys, or difficulty controlling urine (incontinence).

Current treatment options for BPH include open surgery, minimally-invasive surgery, and drug therapy.

“The UroLift provides a less invasive alternative to treating BPH than surgery,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, in a press release. “This device also may offer relief to men who cannot tolerate available drug therapies.”

The UroLift system, manufactured by NeoTract Inc. of Pleasanton, Calf., relieves urinary symptoms by pulling back the prostate tissue pressing against the urethra. The tissue is held in place by a suture anchored to the inside and outside of the prostate.

To deliver the suture, a surgeon inserts the UroLift device into the urethra through a rigid sheath. The tip of the device is positioned in the area of the obstruction and used to push the prostate tissue out of the way.

At that point, the surgeon deploys a needle from the device to deliver the permanent implant. The number of implants depends on the shape and size of the obstruction caused by the enlarged prostate.

One of the main benefits of UroLift is that it offers men with BPH a less-invasive option than open surgery, with no incisions and no cutting or burning away of the prostate tissue. In addition, the results of the procedure can be seen immediately afterwards.

The FDA review was based on two clinical studies of men with BPH who were implanted with two or more UroLift sutures. In both studies, surgeons were able to insert the sutures in 98 percent of cases.

The larger study, published in June in the Journal of Urology, involved 206 men with BPH. The procedure, which is done under local or general anesthesia, took 66 minutes to perform on average.

Twelve months after treatment, men with the UroLift sutures had improved urine flow and were better able to empty their bladders. They also reported a decrease in their symptoms and an increase in their quality of life.

Other minimally-invasive therapies for BPH also access the prostate through the urethra, making the UroLift system similar in this respect. The other procedures, however, involve cutting or burning away excess prostate tissue. UroLift uses only a needle and suture to pull back the prostate tissue.

UroLift is also less invasive than open surgery, a procedure that requires the surgeon to make an incision in the lower abdomen. Open surgery has a greater risk of side effects, but is generally only used for men who have a very large prostate, damage to the bladder, or complicating conditions such as bladder stones.

The side effects reported by men treated with the UroLift system were all minor, and included:

  • pain or burning during urination
  • blood in urine
  • frequent or urgent need to urinate
  • incomplete emptying of the bladder
  • decreased flow of urine

Rare complications, however, can occur when the UroLift procedure—or any surgery—is done using general anesthesia, especially in older men or those with serious medical problems. Serious complications may include lung infections, temporary mental confusion, heart attack, stroke, or death.