Rezūm, Water Vapor Thermal Therapy, Safely and Durably Treats LUTS in Pilot Study

Rezūm, Water Vapor Thermal Therapy, Safely and Durably Treats LUTS in Pilot Study

Convective radiofrequency (RF) water vapor thermal therapy is a safe and effective procedure for improving lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH), according to a recent study.

The research paper, “Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia,” was published in the journal Research and Reports in Urology.

Aiming to improve BPH therapies, researchers at Phelps Memorial Hospital in New York and the Mayo Clinic in Minnesota set up a pilot study (NCT02940392 and NCT02943070), treating men with the thermal treatment in three centers in the Dominican Republic, Czech Republic, and Sweden. Researchers used the Rezūm system to perform the procedure.

The RF water vapor thermal therapy is a minimally invasive procedure that can be performed either in the physician’s office or on an outpatient basis.

The study enrolled 65 patients, 45 years or older, who had not undergone any invasive procedures for their prostate problems. About one-third of the group had moderate LUTS, and two-thirds had severe symptoms. Nearly half, 48 percent, also had a history of problems with impotence.

Before the treatment, patients stopped taking a range of drugs, including BPH medications, anticonvulsants, and antidepressants. Some drugs were allowed if a patient had been on a stable dose for a longer period.

During the two-year follow-up, 22 patients dropped out of the study for various reasons. Four patients had to take additional BPH drugs during the first four months because of lingering symptoms, and one patient resumed treatment after one year.

There were no serious side effects directly linked to the procedure. Although 72 percent of patients were catheterized after the procedure, most needed the catheter only for a few number of days. No patients experienced urinary retention requiring catheterization during the second year of the follow-up.

Treatment resulted in improved an International Prostate Symptom Score (IPSS) after one month. After a year, the reduction was 12.5 points, and this change was maintained throughout the second year.

The study also showed that although the effects of the treatment were larger in the group having more severe symptoms, this difference disappeared after two years.

An improvement of 50 percent or more — exceeding the threshold for a clinically meaningful response — was seen in 60.5 percent of patients, and held throughout the study. Urinary flow improved after three months and remained at a good level.

Treatment also improved the quality of life, although there was no change in measures of sexual function. This finding could be explained by the fact that 44 percent of participants were not sexually active. Researchers also could not detect any clinically meaningful changes in prostate-specific antigen (PSA) levels.

Researchers also examined prostate volume using magnetic resonance imaging (MRI), finding that volumes decreased immediately after the treatment and continued to be lower throughout the study.

Most side effects, 75 percent, were reported during the first month after treatment, and were mild or moderate. They included urinary retention and urinary tract infections.

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