New Options for Benign Prostatic Hypertrophy (BPH) Changing the Treatment Paradigm

By James Ulchaker, MD

The risks inherent in surgical removal of a benign enlarged prostate are well-known. Although many patients have a good outcome, some degree of incontinence or impotence can occur. Because BPH is not life-threatening, it is understandable why some men weigh the risks against the benefits and choose to forego treatment.

Fortunately, new, nonsurgical procedures are improving the experience for surgeons and patients alike.

No surgery required

We were involved in the clinical trials that led to FDA approval of the Rezūm® System (NxThera Inc., Maple Grove, Minnesota) in November 2015, and we now offer it in clinical practice and are proctoring colleagues being trained in the technique.

The Rezūm System employs convective water vapor energy to destroy hyperplastic glandular and stromal cells. Local anesthesia is used, and the procedure’s discomfort is minimal.

First, lidocaine is injected periprostatically. Lidocaine gel is then injected into the urethra, and a specially designed cystoscope is passed up the urethra to the prostate. About 0.42 milliliters of steam is injected into four to 10 zones on the prostate for nine seconds per zone. The procedure is completed in less than five minutes.

A urinary catheter is left in place for three days to compensate for swelling. Patients normally experience urgency and frequency for a period of time. Improvement in urine flow usually begins in about three weeks and is completed in three months.

What is known to date

Experience with the Rezūm System is limited to a handful of medical centers. In our experience, first in clinical trials and, subsequently, in clinical practice, the system has a high satisfaction rate and very low risk of side effects. Neither the ability to have an erection nor ejaculation appear to be significantly affected. Because the urinary sphincter is not damaged during the procedure, the risk of incontinence is very low.

Clinical trials of the Rezūm System were restricted to men with prostates of 80 grams or less. Its effectiveness in larger prostates is now being assessed. As of now, it appears that a single treatment is sufficient, but whether patients will need a second treatment in the future is unknown. We are now hoping to answer these questions in post-market studies.

The Rezūm System has ushered in a new era of patient-friendly treatments. Here at Cleveland Clinic, we are enrolling patients in trials of alternative systems, all with the potential for fewer side effects. As a specialist in BPH, I welcome the opportunity these procedures provide to improve the quality of life for my patients.