Real‐World Long‐Term Outcomes of Rezūm Therapy for Large‐Volume Benign Prostatic Hyperplasia: A Multicenter Cohort Study

ABSTRACT Objectives Benign prostatic hyperplasia (BPH) is a common cause of lower urinary tract symptoms (LUTS) in aging men. Patients with large prostates (≥ 80 mL) often experience more severe symptoms and have limited minimally invasive treatment options. Water vapor thermal therapy (Rezūm) has demonstrated efficacy in moderate‐sized glands, and emerging evidence including multicenter cohorts and systematic reviews suggests efficacy in larger glands. However, long‐term real‐world multicenter data remain limited. This study evaluates the effectiveness of Rezūm therapy in men urinary status outcomes, sexual function, and prostate size in a large, multicenter real‐world cohort with extended follow‐up. Methods We performed a retrospective analysis of a prospectively maintained multicenter registry including patients treated with Rezūm therapy between April 2019 and August 2025 at two high‐volume centers in Canada and Italy. Eligible patients had a baseline prostate volume ≥ 80 mL. Outcomes were assessed at baseline and follow‐up intervals of 6, 12, 24, and 36 months. Primary outcomes included changes in International Prostate Symptom Score (IPSS), quality of life (QoL), BPH Impact Index (BPHII), maximum urinary flow rate ( Q max ), and postvoid residual (PVR). Sexual function was evaluated using the International Index of Erectile Function (IIEF‐15) and the Male Sexual Health Questionnaire (MSHQ). Changes in prostate volume at 12 months were also analyzed. Results A total of 321 patients were included with a mean age of 68.7 years and median prostate volume of 107 mL. Median lobe enlargement was present in 80.1% of patients. Mean IPSS improved from 21.7 ± 6.9 at baseline to 9.9 ± 6.8 at 12 months and 8.4 ± 7.0 at 36 months ( p < 0.001), representing a symptom reduction of up to 62%. QoL scores improved from 4.5 ± 1.1 to 1.6 ± 1.2 at 36 months ( p < 0.001). Qmax increased from 8.1 ± 6.5 mL/s at baseline to 14.6 ± 6.7 mL/s at 6 months, while PVR decreased from 144 ± 136 mL to 48 ± 63 mL at 12 months. Erectile and ejaculatory function remained stable during follow‐up, with retrograde ejaculation reported in 6.2% of patients. Among 172 patients with imaging follow‐up, mean prostate volume decreased by 35.2 mL (29.9%) at 12 months. Conclusions Rezūm therapy provides significant and durable improvements in urinary symptoms and functional outcomes in men with large prostates (≥ 80 mL), while preserving sexual function. These findings support Rezūm as a safe and effective minimally invasive treatment option for large‐volume BPH in real‐world clinical practice.