Gilling Peter J, Barber Neil, Bidair Mohamed, Anderson Paul, Sutton Mark, Aho Tev, Kramolowsky Eugene, Thomas Andrew, Cowan Barrett, Roehrborn Claus
Tauranga Urology Research, Tauranga, New Zealand.
Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, UK.
Urology. 2019 Mar;125:169-173. doi: 10.1016/j.urology.2018.12.002. Epub 2018 Dec 12.
To report 1-year safety and efficacy outcomes after either Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia (BPH) METHODS: This double-blinded, multicenter prospective randomized controlled trial assigned 181 patients with BPH-related moderate-to-severe lower urinary tract symptoms to either electrocautery-based prostate resection (TURP) or Aquablation. Efficacy endpoints included reduction in International Prostate Symptom Score and improvement in uroflow parameters. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher complications.
BPH symptom score improvements were similar across groups with 12-month reduction of 15.1 points after TURP or Aquablation. In both groups, mean maximum urinary flow rates increased markedly postoperatively, with mean improvements of 10.3 cc/s for Aquablation versus 10.6 cc/s for TURP (P = .8632). At 1 year, Prostate-specific antigen (PSA) was reduced significantly (P < .01) in both groups by 1 point; the reduction was similar across groups (P = .9125). Surgical retreatment for BPH rates for TURP were 1.5% and Aquablation 2.6% within 1 year from the study procedure (P = not significant (NS)). The rate of late complications was low, with no procedure-related adverse events after month 6.
The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related complications was low. (ClinicalTrials.gov number, NCT02505919).
报告水刀前列腺切除术或经尿道前列腺电切术(TURP)治疗良性前列腺增生(BPH)相关下尿路症状1年后的安全性和疗效结果。方法:这项双盲、多中心前瞻性随机对照试验将181例BPH相关中重度下尿路症状患者分配至基于电灼的前列腺切除术(TURP)组或水刀前列腺切除术组。疗效终点包括国际前列腺症状评分降低和尿流参数改善。主要安全终点是发生Clavien-Dindo持续性1级或2级及以上并发症。结果:各治疗组BPH症状评分改善情况相似,TURP或水刀前列腺切除术后12个月评分降低15.1分。两组术后平均最大尿流率均显著增加,水刀前列腺切除术组平均增加10.3 cc/s,TURP组平均增加10.6 cc/s(P = 0.8632)。1年后,两组前列腺特异性抗原(PSA)均显著降低1分(P < 0.01);两组降低幅度相似(P = 0.9125)。研究手术后1年内,TURP组BPH再次手术率为1.5%,水刀前列腺切除术组为2.6%(P = 无显著差异(NS))。晚期并发症发生率较低,术后6个月后无手术相关不良事件。结论:TURP和水刀前列腺切除术后1年的结果相似,手术相关晚期并发症发生率较低。(ClinicalTrials.gov编号,NCT02505919)