Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Kidney Stone Fragments vs Observation.

Sorensen, Mathew D; Dunmire, Barbrina; Thiel, Jeff; Cunitz, Bryan W; Burke, Barbara H; Levchak, Branda J; Popchoi, Christina; Holmes, Arturo E; Kucewicz, John C; Hall, M Kennedy; Dighe, Manjiri; Dai, Jessica C; Cormack, Fionnuala C; Liu, Ziyue; Bailey, Michael R; Porter, Michael P; Harper, Jonathan D

Sorensen, Mathew D; Dunmire, Barbrina; Thiel, Jeff; Cunitz, Bryan W; Burke, Barbara H; Levchak, Branda J; Popchoi, Christina; Holmes, Arturo E; Kucewicz, John C; Hall, M Kennedy; Dighe, Manjiri; Dai, Jessica C; Cormack, Fionnuala C; Liu, Ziyue; Bailey, Michael R; Porter, Michael P; Harper, Jonathan D.

Affiliation

Sorensen MD; Department of Urology, University of Washington School of Medicine, Seattle, Washington.
Dunmire B; Division of Urology, Veterans Affairs Puget Sound Health Care System, Seattle, Washington.
Thiel J; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
Cunitz BW; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
Burke BH; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
Levchak BJ; Institute of Translational Health Sciences, University of Washington, Seattle, Washington.
Popchoi C; Seattle Institute for Biomedical and Clinical Research, Veterans Affairs Puget Sound Health Care System, Seattle, Washington.
Holmes AE; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
Kucewicz JC; Department of Urology, University of Washington School of Medicine, Seattle, Washington.
Hall MK; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.
Dighe M; Department of Emergency Medicine, University of Washington School of Medicine, Seattle, Washington.
Dai JC; Department of Radiology, University of Washington School of Medicine, Seattle, Washington.
Cormack FC; EvergreenHealth Urology Care, Kirkland, Washington.
Liu Z; Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington.
Bailey MR; Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, Indiana.
Porter MP; Department of Urology, University of Washington School of Medicine, Seattle, Washington.
Harper JD; Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, Washington.

J Urol ; : 101097JU0000000000004186, 2024 Aug 14.

Article in En | MEDLINE | ID: mdl-39146526

ABSTRACT

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 (11) 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%).