A randomized controlled trial of ultrasonic propulsion-facilitated clearance of residual renal stone fragments versus observation

No AccessJournal of UrologyTranslational Research Article3 Mar 2025A randomized controlled trial of ultrasonic propulsion-facilitated clearance of residual renal stone fragments versus observation Claire C. Yang, Elizabeth E. Keating, Ravi Managuli, Nancy Honssinger, Sarah K. Holt, and Alana C. Desai Claire C. YangClaire C. Yang Correspondence and reprints: Claire C. Yang, M.D. Department of Urology, University of Washington Box 356510, 1959 NE Pacific St. Seattle, WA 98195-6510 USA ([email protected]) +1 206-598-2827 https://orcid.org/0000-0002-4750-6258 , Elizabeth E. KeatingElizabeth E. Keating Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA, USA , Ravi ManaguliRavi Managuli Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA, USA , Nancy HonssingerNancy Honssinger Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA, USA , Sarah K. HoltSarah K. Holt Department of Urology, University of Washington, Seattle, WA, USA , and Alana C. DesaiAlana C. Desai Department of Urology, University of Washington, Seattle, WA, USA View All Author Informationhttps://doi.org/10.1097/JU.0000000000004501AboutPDF Cite Export CitationSelect Citation formatNLMAMAIEEEACMAPAChicagoMLAHarvardTips on citation downloadDownload citationCopy citation ToolsAdd to favoritesTrack Citations ShareFacebookLinked InTwitterEmail Abstract Purpose: In patients with residual stone fragments, ultrasonic propulsion (UP) increased fragment passage rate by 58% and reduced risk of relapse by 70% vs. untreated controls with minor associated adverse events. This study presents a second, independent trial of UP to demonstrate replication of those results and effective training of a novice team of users. Materials and Methods: This was a multi-center, prospective, open label, randomized, controlled trial. Adults with residual fragments ≤ 5 mm seen on clinical imaging at least 4 weeks post-lithotripsy were enrolled. The treatment group underwent UP; the control group did not. The effectiveness endpoints included the proportion of subjects reporting visual observation of stone passage within 3 weeks post-procedure (treatment group) or randomization (controls) and the reduction in stone burden on follow-up imaging captured within 90 days post-procedure/randomization. The safety endpoints were adverse events (AEs) within 3 weeks post-procedure/randomization. Fisher's Exact test was used for comparison. Results: The trial was conducted April - October 2024. Fragments remained a median of 6 months after surgery before study enrollment. Ten of 12 treated participants passed fragments vs. 2 of 12 controls (P=0.003). Nine of 12 treated participants saw stone burden reduction on imaging vs. 1 of 11 controls (P=0.003). All AEs were mild, occurring in 7 of 12 treated participants and 4 of 12 controls. Conclusions: Consistent with the index study, UP conducted by an independent group of operators demonstrated a higher rate of fragment passage and greater reduction in stone burden following UP compared to controls, with minor associated risk. © 2025 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Supplementary Materials Advertisement Copyright & Permissions© 2025 by American Urological Association Education and Research, Inc.KeywordsKidney stonesUltrasoundLithotripsyResidual FragmentsRenal Calculi Author Information Claire C. Yang Correspondence and reprints: Claire C. Yang, M.D. Department of Urology, University of Washington Box 356510, 1959 NE Pacific St. Seattle, WA 98195-6510 USA ([email protected]) +1 206-598-2827 More articles by this author Elizabeth E. Keating Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA, USA More articles by this author Ravi Managuli Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA, USA More articles by this author Nancy Honssinger Center for Industrial and Medical Ultrasound, Applied Physics Laboratory, University of Washington, Seattle, WA, USA More articles by this author Sarah K. Holt Department of Urology, University of Washington, Seattle, WA, USA More articles by this author Alana C. Desai Department of Urology, University of Washington, Seattle, WA, USA More articles by this author Expand All Advertisement PDF downloadLoading ...