Department of Urology, University of Washington School of Medicine, Seattle, Washington.
Division of Urology, Veterans Affairs Puget Sound Health Care System, Seattle, Washington.
J Urol. 2024 Dec;212(6):811-820. doi: 10.1097/JU.0000000000004186. Epub 2024 Aug 15.
Ultrasonic propulsion is an investigational procedure for awake patients. Our purpose was to evaluate whether ultrasonic propulsion to facilitate residual kidney stone fragment clearance reduced relapse.
This multicenter, prospective, open-label, randomized, controlled trial used single block randomization (1:1) without masking. Adults with residual fragments (individually ≤5 mm) were enrolled. Primary outcome was relapse as measured by stone growth, a stone-related urgent medical visit, or surgery by 5 years or study end. Secondary outcomes were fragment passage within 3 weeks and adverse events within 90 days. Cumulative incidence of relapse was estimated using the Kaplan-Meier method. Log-rank test was used to compare the treatment (ultrasonic propulsion) and control (observation) groups.
The trial was conducted from May 9, 2015, through April 6, 2024. Median follow-up (interquartile range) was 3.0 (1.8-3.2) years. The treatment group (n = 40) had longer time to relapse than the control group (n = 42; < .003). The restricted mean time-to-relapse was 52% longer in the treatment group than in the control group (1530 ± 92 days vs 1009 ± 118 days), and the risk of relapse was lower (hazard ratio 0.30, 95% CI 0.13-0.68) with 8 of 40 and 21 of 42 participants, respectively, experiencing relapse. Omitting 3 participants not asked about passage, 24 treatment (63%) and 2 control (5%) participants passed fragments within 3 weeks of treatment. adverse events were mild, transient, and self-resolving, and were reported in 25 treated participants (63%) and 17 controls (40%).
Ultrasonic propulsion reduced relapse and added minimal risk.
CLINICAL TRIAL REGISTRATION NO.: NCT02028559.
超声推进是一种针对清醒患者的研究性操作。我们的目的是评估超声推进是否有助于促进残余肾结石碎片的清除，从而降低复发率。
这是一项多中心、前瞻性、开放标签、随机、对照试验，采用单块随机（1:1），不设盲法。纳入有残余碎片（单个≤5mm）的成年人。主要结局是通过 5 年或研究结束时的结石生长、与结石相关的紧急医疗就诊或手术来衡量的复发。次要结局是 3 周内结石碎片排出和 90 天内不良事件。使用 Kaplan-Meier 法估计复发的累积发生率。对数秩检验用于比较治疗（超声推进）组和对照组（观察）组。
该试验于 2015 年 5 月 9 日至 2024 年 4 月 6 日进行。中位随访时间（四分位间距）为 3.0（1.8-3.2）年。治疗组（n=40）的复发时间长于对照组（n=42；<.003）。治疗组的限制平均复发时间比对照组长 52%（1530±92 天比 1009±118 天），复发风险较低（风险比 0.30，95%CI 0.13-0.68），分别有 8 名/40 名和 21 名/42 名参与者发生复发。忽略 3 名未询问碎片排出情况的参与者，治疗后 24 名/63%参与者和对照组 2 名/5%参与者在 3 周内排出碎片。不良事件轻微、短暂且自限性，在 25 名治疗参与者（63%）和 17 名对照组（40%）中报告。
超声推进降低了复发率，且增加的风险极小。
NCT02028559。
