Institute of Urology, University of Southern California, Los Angeles, CA, USA.
San Diego Clinical Trials, San Diego, CA, USA.
BJU Int. 2019 Aug;124(2):321-328. doi: 10.1111/bju.14703. Epub 2019 Mar 29.
To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL.
Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA.
The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien-Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien-Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction.
Aquablation is safe and effective in treating men with larger prostates (80-150 mL), without significant increase in procedure or resection time.
报告一项多中心前瞻性研究的 6 个月安全性和有效性数据，该研究评估了水刀消融术治疗前列腺体积为 80-150ml、下尿路症状（LUTS）归因于良性前列腺增生（BPH）的男性患者的效果。
2017 年 9 月至 12 月，加拿大和美国的 16 个中心前瞻性纳入了 101 名 LUTS 归因于 BPH 的男性患者。
平均前列腺体积为 107ml。水刀消融术后平均住院时间为 1.6 天（范围：当天至 6 天）。3 个月时主要安全性终点（Clavien-Dindo 分级 2 或更高或任何导致持续性残疾的 1 级事件）发生率为 45.5%，达到了研究设计的<65%（P<0.001）目标。6 个月时，22%的患者发生了 Clavien-Dindo 分级 2 事件，14%的患者发生了分级 3 事件，5%的患者发生了分级 4 事件。出院前有 8 例和出院后有 6 例患者发生需要干预和/或输血的出血并发症。国际前列腺症状评分（IPSS）从基线时的 23.2±6.3 改善至 3 个月时的 6.7±5.1，达到了研究的主要疗效终点目标（P<0.001）。最大尿流率从 8.7 增加到 18.8ml/s（P<0.001），而剩余尿量从基线时的 131 减少到 6 个月时的 47（P<0.0001）。6 个月时，前列腺特异性抗原（PSA）浓度从基线时的 7.1±5.9ng/ml 降低至 4.0±3.9ng/ml，降低了 44%。
水刀消融术治疗前列腺体积为 80-150ml 的男性患者是安全有效的，且不会显著增加手术或切除时间。
