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)
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.
Related
- Prophylactic endoscopic transpapillary gallbladder stenting at fully covered self-expandable metal stent placement to prevent cholecystitis in malignant distal biliary obstruction: A multicenter prospective single-arm study protocol (PROTECT study)
- Individualized Or Conventional Transfusion Strategy During Veno-Arterial Extracorporeal Membrane Oxygenation Support (ICONE Study): Rationale and Design of a Prospective Multicenter Randomized Controlled Trial
- Assessment of blinding in pharmacotherapy and noninvasive neuromodulation randomized controlled trials for neuropathic pain in adults
- Evaluating the efficacy and safety of therapeutic plasma exchange in snakebite-associated thrombotic microangiopathy compared to standard care alone: study protocol for a multicenter randomized controlled trial
- Evolution of temporomandibular joint-related clinical findings and patient reported quality of life after orthognathic surgery: a prospective multicenter study
BibTeX
@article{vincendeau2026water,
title = {{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)}},
author = {Sébastien Vincendeau and Evanguelos Xylinas and Marc Fourmarier and Ismael Galliot and Ambroise Salin and Souhil Lebdai and Jonathan Olivier and Paul Anderson and Charles Ballereau and Florian Laclergerie and Eric Barret and Vincent Misraï and Hakim Fassi-Fehri and Matthieu Durand and Richard Mallet and Quentin Franquet and Grégoire Robert and Lucie-Marie Scailteux and Caroline Beaudoint and Patrick O'Connor and Isabelle Searcy and Kathryn Goodrich and Jean‐nicolas Cornu and Romain Mathieu},
journal = {European Urology Focus},
year = {2026},
month = sep,
doi = {10.1016/j.euf.2026.08.001},
url = {https://univ-rennes.hal.science/hal-05771936v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - 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)
AU - Sébastien Vincendeau
AU - Evanguelos Xylinas
AU - Marc Fourmarier
AU - Ismael Galliot
AU - Ambroise Salin
AU - Souhil Lebdai
AU - Jonathan Olivier
AU - Paul Anderson
AU - Charles Ballereau
AU - Florian Laclergerie
AU - Eric Barret
AU - Vincent Misraï
AU - Hakim Fassi-Fehri
AU - Matthieu Durand
AU - Richard Mallet
AU - Quentin Franquet
AU - Grégoire Robert
AU - Lucie-Marie Scailteux
AU - Caroline Beaudoint
AU - Patrick O'Connor
AU - Isabelle Searcy
AU - Kathryn Goodrich
AU - Jean‐nicolas Cornu
AU - Romain Mathieu
PY - 2026
DA - 2026/09/30
JO - European Urology Focus
DO - 10.1016/j.euf.2026.08.001
UR - https://univ-rennes.hal.science/hal-05771936v1
AB - 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.
SN - 2405-4569
ER -