Institute of Urology, University of Southern California, Los Angeles, CA, USA.
San Diego Clinical Trials, San Diego, CA, USA.
BJU Int. 2019 Jan;123(1):106-112. doi: 10.1111/bju.14360. Epub 2018 Jun 10.
To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large-volume benign prostatic hyperplasia (BPH).
Between September and December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volume of 80-150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra-operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee.
The mean (range) prostate volume was 107 (80-150) mL. The mean (range) operating time was 37 (15-97) min and aquablation resection time was 8 (3-15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien-Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri-operative transfusions.
Aquablation is feasible and safe in treating men with men with large prostates (80-150 mL). The 6-month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).
介绍一项多中心前瞻性研究（WATER II）的早期安全性和可行性数据，该研究评估了经尿道水消融术治疗大体积良性前列腺增生（BPH）的疗效。
2017 年 9 月至 12 月，101 例中重度 BPH 症状且前列腺体积为 80-150ml 的男性患者参与了这项多中心国际临床试验，接受了经尿道水消融术治疗。在中央独立监测数据库中，详细记录了基线人口统计学和标准化术后管理变量。外科医生回答了术中技术因素和术后管理的模拟量表问卷。术后 1 个月内的不良事件由独立临床事件委员会裁定。
平均（范围）前列腺体积为 107（80-150）ml。平均（范围）手术时间为 37（15-97）min，水消融切除时间为 8（3-15）min。34 例患者仅用 1 次通过即可达到足够的腺瘤切除，67 例患者（平均 1.8 次治疗通过）需要额外的通过才能完成切除，所有患者均在单个手术过程中完成。98 例患者（平均持续时间 18 小时）使用膀胱牵引下的 Foley 球囊导管止血，3 例患者（平均持续时间 15 小时）使用前列腺窝内充气的球囊直接填塞止血。没有患者在初次手术时需要电凝止血。术后平均住院时间为 1.6 天（范围为当天至 6 天）。术后 1 个月时观察到的 Clavien-Dindo 分级≥2 事件发生率为 29.7%。10 例患者（9.9%）在出院前的索引手术住院期间发生出血并发症，其中 6 例（5.9%）接受了围手术期输血。
经尿道水消融术治疗大体积前列腺（80-150ml）是安全可行的。正在收集 6 个月的疗效数据，并将在未来的出版物中呈现（ClinicalTrials.gov 编号：NCT03123250）。
