Hinata Nobuyuki, Fujisawa Masato, Yamaguchi Raizo, Katsura Daiki, Kitano Hiroyuki, Sekino Yohei, Yoshioka Kunihiko, Koike Shin, Odagaki Yu, Ozawa Yu, Aoki Keisuke, Miyauchi Toshihide, Watanabe Susumu, Barber Neil, Elterman Dean, Afshar Ali, Saito Keisuke, Ide Hisamitsu, Horie Shigeo
Department of Urology, Hiroshima University Graduate School of Biomedical Sciences, Hiroshima, Hiroshima Prefecture, Japan.
Department of Urology, Kobe University Graduate School of Medicine, Kobe, Hyōgo Prefecture, Japan.
Int J Urol. 2025 Mar;32(3):308-313. doi: 10.1111/iju.15651. Epub 2024 Dec 13.
To evaluate the safety, efficacy, and patient-reported outcomes of Aquablation therapy using the AQUABEAM Robotic System for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in a Japanese population.
This post-market use-results survey included 103 Japanese men with BPH who underwent Aquablation across five centers with previously Aquablation naïve physicians. Data were collected at baseline, during the procedure, at discharge, and at 3 and 6 months post-procedure. Key outcomes included International Prostate Symptom Score (IPSS), quality of life (QoL), uroflowmetry parameters, and adverse events.
The mean age of patients was 71.1 years, and the average prostate size was 82.3 mL. At 6 months, the mean IPSS significantly improved from 18.1 ± 9.0 to 6.1 ± 5.0 (p < 0.0001), and QoL scores improved from 4.9 ± 1.3 to 1.8 ± 1.3 (p < 0.0001). Uroflowmetry showed a significant increase in Qmax from 8.3 ± 4.4 to 15.5 ± 7.8 mL/s (p < 0.0001) and a decrease in post-void residual volume (PVR) from 85.6 ± 107.2 to 43.3 ± 60.0 mL (p = 0.0006). At the 30-day primary safety endpoint, there were no reported adverse events of pad-use incontinence, erectile dysfunction, or ejaculatory dysfunction reported, and no device-related serious adverse events were reported. One subject (0.97%) experienced a Clavien-Dindo grade 3 adverse event.
Aquablation therapy using the AQUABEAM Robotic System is a reproducible, safe, and effective treatment for Japanese men with BPH, providing significant improvements in LUTS and QoL with a favorable safety profile.
评估使用AQUABEAM机器人系统进行水消融疗法治疗日本人群中因良性前列腺增生(BPH)导致的下尿路症状(LUTS)的安全性、有效性和患者报告的结局。
这项上市后使用结果调查纳入了103名患有BPH的日本男性,他们在五个中心接受了水消融治疗,治疗医生之前未进行过水消融治疗。在基线、手术期间、出院时以及术后3个月和6个月收集数据。主要结局包括国际前列腺症状评分(IPSS)、生活质量(QoL)、尿流率参数和不良事件。
患者的平均年龄为71.1岁,平均前列腺体积为82.3 mL。在6个月时,平均IPSS从18.1±9.0显著改善至6.1±5.0(p<0.0001),QoL评分从4.9±1.3改善至1.8±1.3(p<0.0001)。尿流率显示最大尿流率(Qmax)从8.3±4.4显著增加至15.5±7.8 mL/s(p<0.0001),排尿后残余尿量(PVR)从85.6±107.2减少至43.3±60.0 mL(p=0.0006)。在30天的主要安全终点,未报告使用尿垫失禁、勃起功能障碍或射精功能障碍的不良事件,也未报告与设备相关的严重不良事件。一名受试者(0.97%)经历了Clavien-Dindo 3级不良事件。
使用AQUABEAM机器人系统进行水消融疗法对于患有BPH的日本男性是一种可重复、安全且有效的治疗方法,可显著改善LUTS和QoL,并具有良好的安全性。