Rezūm outperforms combination pharmacotherapy for BPH symptoms at 1 year

A head-to-head randomized trial comparing Rezūm water vapor thermal therapy directly against combination pharmacotherapy in men with benign prostatic hyperplasia (BPH) already on alpha-blockers found that Rezūm produced significantly greater symptom improvement at 1 year—with a clinically meaningful difference exceeding the threshold at which patients can perceive a change, according to Jean-Nicolas Cornu, MD, PhD, FEBU.¹

The trial was designed to address a specific gap in the evidence base. Prior Rezūm data came from comparisons with sham or from prospective single-arm studies; no level-one evidence existed comparing the procedure directly to an active pharmacologic reference.

"We had data for Rezūm compared to sham, and data from prospective trials, but we didn't have a comparison directly to a reference treatment," Cornu said. The study also targeted a practical patient pathway: men already on an alpha-blocker who would typically be escalated to combination therapy—the addition of a 5-alpha reductase inhibitor—rather than those naive to any treatment.

"This was quite pragmatic because it corresponds to a lot of patients, especially in France, where a lot of people on alpha-blockers get combination therapy," he said.

Sexual function was selected as a co-primary end point alongside symptom improvement, reflecting the clinical profile of the target population and the importance patients in this setting place on preserving sexual health.

At 1 year, the primary end point favored Rezūm. Mean International Prostate Symptom Score (IPSS) improvement was 10.8 points in the Rezūm arm vs 6.2 points in the combination pharmacotherapy arm, a difference of 4.6 IPSS points that was both statistically significant and clinically meaningful. The 3-point IPSS threshold, established in prior literature as the minimum difference perceptible to patients, was surpassed. Quality-of-life outcomes followed the same pattern, correlating with the symptom benefit.

"The patients who got the Rezūm did better at 1 year," Cornu said. "Having those correlations is quite usual in males, but it was obviously very comfortable to have this correlation very clear in our paper."

Reference

1. Vincendeau S, Xylinas E, Fourmarier M, et al. Water vapor thermal therapy with Rezūm versus combination pharmacotherapy for male lower urinary tract symptoms due to benign prostatic obstruction: 1-yr results from a prospective, multicenter, pragmatic randomized controlled trial (VAPEUR-RCT). Eur Urol Focus. 2026 Aug 18:S2405-4569(26)00175-6. doi:10.1016/j.euf.2026.08.001