A More Patient-Friendly Option for Treating Enlarged Prostates

FDA Approved Rezūm® System: A New, Safer Approach for BPH

Anterior view showing normal versus enlarged prostate gland
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About half of men older than age 75 get out of bed several times a night to urinate. For many, the issue is an enlarged prostate gland. Although an enlarged prostate gland can be caused by prostate cancer, often it’s the result of a noncancerous condition called benign prostatic hypertrophy (BPH).

Urine flow can be improved by surgically removing the prostate. But this method is not entirely risk-free.

Some degree of incontinence or impotence is normal. Since BPH is not a dangerous condition, many men choose instead to simply suffer in silence.

Last year, the Food and Drug Administration (FDA) approved the Rezūm® System, which takes an entirely new, safer approach to treating BPH. The simple, five-minute office procedure restores proper urine flow with a low risk of side effects. By doing so, this procedure has the potential to improve the quality of life for millions of men.

Unfortunate Anatomy

The urethra—the tube that empties the bladder—passes directly through the walnut-sized prostate gland. Prostate tissues grow as men age, which enlarges the gland and squeezes the urethra like a belt being gradually tightened around the waist. This makes it increasingly hard to empty the bladder completely at one time. Despite the urge to urinate, a trickle at a time becomes the norm.

A Totally New Approach

An alternative to surgery, the Rezūm® System uses steam to kill cells.

Here’s how it works:

  • Lidocaine is injected to numb the nerves leading to the prostate.
  • Lidocaine gel is then injected into the urethra to enable the urologist to pass a specially designed cystoscope through the urethra to the prostate. (No general or spinal anesthesia is required, and the procedure is not painful.)
  • The urologist selects four to 10 zones on the prostate and injects a tiny amount of steam into each. The steam kills the tissue, which the body simply reabsorbs. Each injection takes nine seconds and the procedure is over in less than five minutes.

Waiting and Watching

Men leave the office with a urinary catheter which is left in place for three days to compensate for swelling. Afterward, it is normal to experience a sense of urgency and frequency to urinate for a period of time. Improvement is not immediate. However, some improvement in urine flow is usually seen in about three weeks. Dramatic improvement takes three months.

What's Known

Because the Rezūm® System is rather new, physicians have limited experience with it. In clinical trials, the procedure was used in men with ​prostates of a certain size. How well the technique works in larger prostates is now being tested.

No major medical complications from the procedure have been reported. Because the steam heat stays in the prostate, the ability to ejaculate or have an erection is unaffected.

And because the treatment does not damage the urinary sphincter, the risk of incontinence is very low.

Long-term results of the Rezūm® System are not yet available. Whether a second treatment will be needed in the future and, if so, how far into the future is still unknown. Evaluating the post-clinical trial results is currently underway with the hopes of answering some of these questions soon.

Getting Treatment

After the FDA approved the Rezūm® System, the company that developed the procedure allowed some medical centers involved in the clinical trials, including Cleveland Clinic, to offer it to patients. Cleveland Clinic began using the treatment in February 2016 and has been quite satisfied with the results, even teaching colleagues nationwide how to perform the procedure.

The Rezūm® System has ushered in an era of more patient-friendly treatments for a common problem. Fortunately, it’s just the beginning. We are now enrolling patients in clinical trials of three different systems for treating BPH, all with the potential for fewer side effects.

Dr. Ulchaker is a urologist specializing in BPH at the Prostate Center at Cleveland Clinic’s Glickman Urological and Kidney Institute, the nation’s No. 2 urology program as ranked by U.S. News & World Report.

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