Mathew D Sorensen, Barbrina Dunmire, Jeff Thiel, Bryan W Cunitz, Barbara H Burke, Branda J Levchak, Christina Popchoi, Arturo E Holmes, John C Kucewicz, M Kennedy Hall, Manjiri Dighe, Jessica C Dai, Fionnuala C Cormack, Ziyue Liu, Michael R Bailey, Michael P Porter, Jonathan D Harper
J Urol. 2024 Dec;212(6):811-820. doi: 10.1097/JU.0000000000004186
Abstract
Purpose: 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.
Materials and methods: 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.
Results: 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; P < .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%).
Conclusions: Ultrasonic propulsion reduced relapse and added minimal risk.
Comment Hans-Göran Tiselius
Almost 40 years of experience with SWL has taught me that the major remaining clinical problem with this method is to get rid of residual fragments in the lower calyces. Pain treatment and disintegration of stones are usually not significant problems, but fragments in the lower calyces are!
Different tricks for fragment elimination such as inversion and percussion/vibration procedures have been helpful, but never as effective as expected.
It is therefor with enthusiasm I read the article on ultrasonic propulsion. This method is presented as an office alternative to more invasive procedures.
Repositioning of fragments with ultrasound pulses to facilitate their elimination appears effective and possible to include in the clinical routine. The result is impressive and further fine-tuning of the method might give us the tool for fragment elimination from the lower calyx that we have been looking for.
There is reference to a video https://www.jurology.com, but it was not possible for me to open that file.
This is the top-publication of period 4 2024!
Hans-Göran Tiselius