You have accessJournal of UrologyLate-breaking Abstract I - Benign1 Sep 2021LBA01-06 RANDOMIZED CONTROL TRIAL OF ULTRASONIC PROPULSION TO FACILITATE CLEARANCE OF CHRONIC RESIDUAL FRAGMENTS Mathew D. Sorensen, Jessica C. Dai, Tony T. Chen, Peter Sunaryo, Barbrina Dunmire, Jeff Thiel, Michael Porter, Branda J. Levchak, Barbara H. Burke, Christina Popchoi, Bryan W. Cunitz, Ziyue Liu, Michael R. Bailey, and Jonathan D. Harper Mathew D. SorensenMathew D. Sorensen More articles by this author , Jessica C. DaiJessica C. Dai More articles by this author , Tony T. ChenTony T. Chen More articles by this author , Peter SunaryoPeter Sunaryo More articles by this author , Barbrina DunmireBarbrina Dunmire More articles by this author , Jeff ThielJeff Thiel More articles by this author , Michael PorterMichael Porter More articles by this author , Branda J. LevchakBranda J. Levchak More articles by this author , Barbara H. BurkeBarbara H. Burke More articles by this author , Christina PopchoiChristina Popchoi More articles by this author , Bryan W. CunitzBryan W. Cunitz More articles by this author , Ziyue LiuZiyue Liu More articles by this author , Michael R. BaileyMichael R. Bailey More articles by this author , and Jonathan D. HarperJonathan D. Harper More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002148.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The goal is to test effectiveness and safety of transcutaneous ultrasound pulses for facilitating clearance of residual urinary stone fragments in a randomized control trial (RCT) conducted across two sites. METHODS: Thirty-three subjects will be recruited to each arm. The study is conducted in a clinic setting with the control and treatment arms undergoing all the same activities with the exception of the ultrasonic propulsion procedure and associated pain questionnaire. Subjects are followed 90 days for assessment of adverse events and for up to 5 years for stone growth and symptomatic stone visits. RESULTS: Twenty-six subjects have been recruited in each arm on pace to complete enrollment in 2021. As the RCT is incomplete, the most recent treatment is reported. A computed tomography intravenous pyelogram of the left kidney from June 13, 2016 shows the anatomy (Fig. 1). The 38-year-old male with Crohn’s disease was otherwise healthy and received shock wave lithotripsy on January 2, 2020 for a left lower pole stone. He reported passing no fragments. Seven imaging exams confirmed a stable lower pole collection of fragments. The subject was randomized to the treatment arm on May 28, 2021. Fragments began moving with the third 3-s propulsion pulse at output 2 of 5 levels. Fifty-two percent of propulsion pulses (41 of 79) resulted in fragment movement (Fig. 2). Ultrasound viewers counted fewer than 10 fragments. The subject reported no pain at the beginning or end of the procedure and on his own accord telephoned within hours to report passing 9 fragments, no hematuria, and no adverse events. CONCLUSIONS: The treatment results of this RCT are compelling as an immediate and casual effect is measured. The most recent subject did not pass fragments for 17 months and then saw fragments repositioned to the pelvis in real-time and nine fragments pass within hours of treatment. The subject reported no adverse events. Source of Funding: Work supported by NIH NIDDK grant P01 DK043881 © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1172-e1172 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mathew D. Sorensen More articles by this author Jessica C. Dai More articles by this author Tony T. Chen More articles by this author Peter Sunaryo More articles by this author Barbrina Dunmire More articles by this author Jeff Thiel More articles by this author Michael Porter More articles by this author Branda J. Levchak More articles by this author Barbara H. Burke More articles by this author Christina Popchoi More articles by this author Bryan W. Cunitz More articles by this author Ziyue Liu More articles by this author Michael R. Bailey More articles by this author Jonathan D. Harper More articles by this author Expand All Advertisement Loading ...