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).
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
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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.
背景和目的：VAPEUR随机对照试验比较了Rezūm水蒸气热疗法（WVTT）与联合药物治疗（CP； α -受体阻滞剂加5- α -还原酶抑制剂）对症状性良性前列腺阻塞（BPO）的性活跃男性的治疗效果。方法：151名男性被随机分为WVTT组（n = 75）和CP组（n = 76）。国际前列腺症状评分（IPSS）和男性性健康问卷（MSHQ）评分的主要终点从基线到1年发生变化。次要终点包括复发症状的手术/药物治疗，≥4分IPSS恶化（ΔIPSS≥4），以及术后90 d以上的导管。主要发现和局限性：在1年时，WVTT组IPSS的改善大于CP组（平均差值为-4.6分；97.5%置信区间[CI] -7.6至-1.6;p < 0.001），平均改善分别为10.8±6.8分和6.2±7.7分。MSHQ评分与WVTT（+1.1±16.9）和CP（-5.2±16.4）保持稳定。在保留性功能方面的优势并没有被多次植入证明。WVTT组的生活质量（QoL）改善更大（-2.7±1.8 vs -1.8±2.0;p = 0.01）。WVTT导致手术再治疗率（1.3% vs 9.2%）、ΔIPSS≥4 （2.7% vs 13%）和90 d后置管率（0% vs 1.3%）较低，但药物再治疗率较高（12% vs 1.3%；综合：风险比= 0.52,CI 0.25-1.1, p = 0.08）。治疗相关不良事件（ae）在WVTT中更为常见（40% vs 28%；严重ae， 12% vs 1.3%），主要与手术相关；1年时，WVTT患者的症状缓解率为93%，而CP患者的症状缓解率为60%（25/42）。结论和临床意义：与CP相比，WVTT在1年时提供了更好的症状缓解和更大的生活质量改善，同时保留了性功能。这些发现支持WVTT作为CP的有效替代。
期刊介绍：
European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU).
EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.
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