AQUABEAM 机器人系统使用效果调查:日本人口中用于治疗良性前列腺增生引起的下尿路症状的水消融术。

IF 1.8 3区 医学 Q3 UROLOGY & NEPHROLOGY International Journal of Urology Pub Date : 2024-12-13 DOI:10.1111/iju.15651
Nobuyuki Hinata, Masato Fujisawa, Raizo Yamaguchi, Daiki Katsura, Hiroyuki Kitano, Yohei Sekino, Kunihiko Yoshioka, Shin Koike, Yu Odagaki, Yu Ozawa, Keisuke Aoki, Toshihide Miyauchi, Susumu Watanabe, Neil Barber, Dean Elterman, Ali Afshar, Keisuke Saito, Hisamitsu Ide, Shigeo Horie
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引用次数: 0

摘要

目的:评估日本人群中使用AQUABEAM机器人系统治疗由良性前列腺增生(BPH)引起的下尿路症状(LUTS)的安全性、有效性和患者报告的结果。方法:这项上市后使用结果调查包括103名日本男性BPH患者,他们在5个中心接受了先前的Aquablation naïve医生的治疗。在基线、手术过程中、出院时以及手术后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)、尿流测量参数和不良事件。结果:患者平均年龄71.1岁,平均前列腺大小82.3 mL。6个月时,平均IPSS从18.1±9.0显著提高到6.1±5.0 (p)。结论:使用AQUABEAM机器人系统对日本男性BPH患者进行水消融治疗是一种可重复、安全、有效的治疗方法,可显著改善LUTS和QoL,并具有良好的安全性。
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AQUABEAM robotic system use-results survey: Aquablation for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia in the Japanese Population.

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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来源期刊
International Journal of Urology
International Journal of Urology 医学-泌尿学与肾脏学
CiteScore
4.70
自引率
11.50%
发文量
340
审稿时长
3 months
期刊介绍: International Journal of Urology is the official English language journal of the Japanese Urological Association, publishing articles of scientific excellence in urology. Submissions of papers from all countries are considered for publication. All manuscripts are subject to peer review and are judged on the basis of their contribution of original data and ideas or interpretation.
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