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)
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: European Urology Focus
Authors: Sébastien Vincendeau, Evanguelos Xylinas, Marc Fourmarier, Ismael Galliot, Ambroise Salin, Souhil Lebdai, Jonathan Olivier, Paul Anderson, Charles Ballereau, Florian Laclergerie, Eric Barret, Vincent Misraï, Hakim Fassi–Fehri, Matthieu Durand, Richard Mallet, Quentin Franquet, Grégoire Robert, Lucie–Marie Scailteux, Caroline Beaudoint, Patrick O’Connor, Isabelle Searcy, Kathryn Goodrich, Jean–Nicolas Cornu, Romain Mathieu
Institutions: Centre Hospitalier privé Saint Grégoire, Assistance Publique – Hôpitaux de Paris, Hôpital Bichat-Claude-Bernard, Centre Hospitalier Intercommunal Aix-Pertuis, Centre Hospitalier Universitaire d'Angers, Centre Hospitalier Universitaire de Lille, Ipswich Hospital, Richmond Royal Hospital, Centre Hospitalier Universitaire de Toulouse, Clinique Pasteur, Hospices Civils de Lyon, Hôpital Pasteur, Centre Hospitalier Universitaire de Grenoble, Centre Hospitalier Universitaire de Bordeaux, Inserm, Institut de Recherche en Santé, Environnement et Travail, Centre Hospitalier Universitaire de Rennes, Université de Rennes, Boston Scientific (Belgium), Boston Scientific (United States), Centre Hospitalier Universitaire de Rouen, École des Hautes Études en Santé Publique
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,800
Funder: Boston Scientific Corporation
OpenAlex ID: W7203677178