Gilling Peter, Anderson Paul, Tan Andrew
Tauranga Hospital, Bay of Plenty District Health Board, Tauranga, New Zealand.
Royal Melbourne Hospital, Melbourne, Victoria.
J Urol. 2017 Jun;197(6):1565-1572. doi: 10.1016/j.juro.2017.01.056. Epub 2017 Jan 20.
We sought to establish the safety and effectiveness of aquablation, a novel, image guided, robotic assisted, water jet tissue ablation technology, for the treatment of benign prostatic hyperplasia.
We performed a prospective, single arm, multicenter trial at a total of 3 centers in Australia and New Zealand with 1-year followup. Participants were men 50 to 80 years old with moderate to severe lower urinary tract symptoms as determined by urodynamics. All patients underwent aquablation under image guidance. Primary end points included procedural and perioperative safety. The main clinical end point was the change from baseline in I-PSS (International Prostate Symptom Score). Other secondary end points included uroflow measures, prostate volume on transrectal ultrasound and detrusor pressure. Detrusor pressure at maximum flow was only measured at 6 months.
A total of 21 men underwent aquablation at a mean age of 69.7 years (range 62 to 78). Prostate volume was 57.2 ml (range 30 to 102). Procedural duration averaged 38 minutes with a mean aquablation treatment time of 5 minutes. All but 1 subject were catheterized for 1 day only and 19 of 21 were discharged home the day after the procedure. Detrusor pressure at maximum flow decreased from 65 cm HO at baseline to 39 cm HO at 6 months (p <0.0027). Prostate volume decreased from 57 ml at baseline to 35 ml (p <0.0001). Mean I-PSS score improved from 23.0 at baseline to 6.8 at 12 months (p <0.0001) and maximum urinary flow increased from 8.7 to 18.3 ml per second (p <0.0001). There were no important perioperative adverse events. No urinary incontinence developed and sexual function was preserved postoperatively.
This phase II study provides early evidence to support the safety and effectiveness of aquablation for symptomatic benign prostatic hyperplasia.
我们试图确立水刀消融术（一种新型的、图像引导的、机器人辅助的水刀组织消融技术）治疗良性前列腺增生的安全性和有效性。
我们在澳大利亚和新西兰的3个中心进行了一项前瞻性、单臂、多中心试验，并进行了1年的随访。参与者为年龄在50至80岁之间、经尿动力学检查确定有中度至重度下尿路症状的男性。所有患者均在图像引导下接受水刀消融术。主要终点包括手术和围手术期安全性。主要临床终点是国际前列腺症状评分（I-PSS）相对于基线的变化。其他次要终点包括尿流测量、经直肠超声检查的前列腺体积和逼尿肌压力。最大尿流时的逼尿肌压力仅在6个月时测量。
共有21名男性接受了水刀消融术，平均年龄为69.7岁（范围62至78岁）。前列腺体积为57.2毫升（范围30至102毫升）。手术持续时间平均为38分钟，水刀消融治疗平均时间为5分钟。除1名受试者外，所有受试者仅留置导尿管1天，21名受试者中有19名在术后第二天出院。最大尿流时的逼尿肌压力从基线时的65 cm H₂O降至6个月时的39 cm H₂O（p<0.0027）。前列腺体积从基线时的57毫升降至35毫升（p<0.0001）。平均I-PSS评分从基线时的23.0改善至12个月时的6.8（p<0.0001），最大尿流率从每秒8.7毫升增加至1秒18.3毫升（p<0.0001）。围手术期无重大不良事件。未发生尿失禁，术后性功能得以保留。
这项II期研究提供了早期证据，支持水刀消融术治疗有症状的良性前列腺增生的安全性和有效性。
