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).

BACKGROUND AND OBJECTIVE: The VAPEUR randomized controlled trial compared Rezūm water vapor thermal therapy (WVTT) with combination pharmacotherapy (CP; alpha-blockers plus 5-alpha-reductase inhibitors) in sexually active men with symptomatic benign prostatic obstruction (BPO). METHODS: Overall, 151 men were randomized to WVTT (n = 75) or CP (n = 76). Primary endpoints changed from baseline to 1 yr in the International Prostate Symptom Score (IPSS) and Male Sexual Health Questionnaire (MSHQ) score. Secondary endpoints included surgical/medical treatment for recurring symptoms, ≥4 points IPSS worsening (ΔIPSS ≥4), and catheterization beyond 90 d post-procedure. KEY FINDINGS AND LIMITATIONS: At 1 yr, IPSS improvement was greater with WVTT than CP (mean difference -4.6 points; 97.5% confidence interval [CI] -7.6 to -1.6; p < 0.001), with mean improvements of 10.8 ± 6.8 versus 6.2 ± 7.7 points, respectively. MSHQ scores remained stable with WVTT (+1.1 ± 16.9) and CP (-5.2 ± 16.4). Superiority in preserving sexual function was not demonstrated with multiple imputation. Quality‑of‑life (QoL) improvement was greater with WVTT (-2.7 ± 1.8 vs -1.8 ± 2.0; p = 0.01). WVTT resulted in lower rates of surgical retreatment (1.3% vs 9.2%), ΔIPSS ≥4, (2.7% vs 13%) and post-90 d catheterization (0% vs 1.3%), but higher pharmacological retreatment (12% vs 1.3%; combined: hazard ratio = 0.52, CI 0.25-1.1, p = 0.08). Treatment‑related adverse events (AEs) were more frequent with WVTT (40% vs 28%; serious AEs, 12% vs 1.3%), largely procedure‑related; at 1 yr, 93% were resolved in WVTT versus 60% (25/42) in CP. CONCLUSIONS AND CLINICAL IMPLICATIONS: At 1 yr, WVTT provides superior symptom relief and greater QoL improvement versus CP, while preserving sexual function. These findings support WVTT as an effective alternative to CP.