Evaluating the effectiveness and safety of Rezum water vapor therapy in real-world patients with benign prostatic hyperplasia.

This study evaluated the effectiveness and safety of Rezum water vapor therapy in real-world patients with benign prostatic hyperplasia (BPH). The data showed that Rezum water vapor therapy was safe and effective in these patients.

Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland. These patients often experience lower urinary tract symptoms (LUTS). These include symptoms such as difficulties emptying the bladder, urine leakage, or getting up to urinate during the night. Standard treatments for BPH involve surgical procedures and medications that can often impact ejaculation and sexual function. Another option for these patients is a minimally invasive treatment procedure which is associated with preserving sexual function.

Rezum water vapor therapy is a minimally invasive procedure consisting of delivering thermal energy in the form of steam to the prostate tissue blocking urine flow. This will remove excess prostatic tissue improving the urinary symptoms. Previous studies have shown that it may be associated with better functional outcomes. However, in clinical trials, patients are carefully selected to be fit and without additional medical conditions. Therefore, the effectiveness and safety of Rezum water vapor therapy in real-world patients with BPH are not known.

This study involved 229 patients with BPH (prostate volumes of 20-160 ml). Patients were treated by intraprostatic water vapor injections using the Rezum system. The International Prostate Symptom Score (IPSS) was measured before and after treatment. This questionnaire can be used to screen for, rapidly diagnose, and track the symptoms of LUTS. Quality of life (QoL), erectile function, maximum urine flow rate, and the volume of urine left in the bladder after urination were also measured. Patients were followed up at 1, 3, 6, and 12 months after the procedure.

The average prostate volume was 71.5 mL. 36% (83) of the patients had a prostate volume of 80 mL or more. 55% of the patients had a median lobe. The average number of injections was 11 and the average time of the procedure was 4.8 minutes. The urinary catheter removal was done after an average of 9.8 days.

The average total IPSS scores improved by 29% at 1 month, by 53% at 3 months, by 62% at 6 months, and by 59% at 12 months from the start of treatment. The average total IPSS scores measuring the QoL of the patients improved by 30% at 1 month, by 50% at 3 months, by 61% at 6 months, and by 67% at 12 months from the start of treatment.  

The maximum urine flow rate improved by 55% at 1 month, by 60% at 3 months, by 71% at 6 months, and by 74% at 12 months from the start of treatment. The volume of urine left in the bladder after urination improved by 63% at 1 month, by 51% at 3 months, by 58% at 6 months, and by 61% at 12 months from the start of treatment.  

There were no significant differences in erectile function, sexual function, and sexual satisfaction at all time points from the start of the treatment. There were no serious side effects.

This study concluded that Rezum water vapor therapy was safe and effective in real-world patients with BPH.

This study did not have a comparison group. The patients knew which treatment they were getting. This study only included Canadian patients.