Pd50-07 defining stone passage in a clinical trial: adjudication in the prevention of urinary stones with hydration (push) study

You have accessJournal of UrologyCME1 May 2022PD50-07 DEFINING STONE PASSAGE IN A CLINICAL TRIAL: ADJUDICATION IN THE PREVENTION OF URINARY STONES WITH HYDRATION (PUSH) STUDY Hunter Wessells, Henry Lai, John Lieske, Brian Matlaga, Sharon Settles, Hongqiu Yang, Jonathan Harper, Charles Scales, Alana Desai, Naim Maalouf, Peter Reese, Sri Sivalingam, Gregory Tasian, Hussein Al-Khalidi, and Ziya Kirkali Hunter WessellsHunter Wessells More articles by this author , Henry LaiHenry Lai More articles by this author , John LieskeJohn Lieske More articles by this author , Brian MatlagaBrian Matlaga More articles by this author , Sharon SettlesSharon Settles More articles by this author , Hongqiu YangHongqiu Yang More articles by this author , Jonathan HarperJonathan Harper More articles by this author , Charles ScalesCharles Scales More articles by this author , Alana DesaiAlana Desai More articles by this author , Naim MaaloufNaim Maalouf More articles by this author , Peter ReesePeter Reese More articles by this author , Sri SivalingamSri Sivalingam More articles by this author , Gregory TasianGregory Tasian More articles by this author , Hussein Al-KhalidiHussein Al-Khalidi More articles by this author , and Ziya KirkaliZiya Kirkali More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002621.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Clinical trials in patients with urinary stone disease have used variable definitions of stone events/ passage. We assessed the accuracy of self-reported stone passage in a large clinical trial using a blinded adjudication process. METHODS: Study participants (n=1642) in the two arm PUSH trial are randomized either to a behavioral intervention or control arm to increase and maintain high fluid intake. The primary endpoint is symptomatic kidney stone recurrence including stone passage observed and/or captured by the participant or procedural intervention for stones. Adjudication of the primary endpoint (Confirmed Event) requires corroboration via photograph, stone specimen, imaging, definitive record of symptoms (pain, nausea/vomiting, urinary symptoms, hematuria) and passage and/or surgical intervention in clinical notes. A Suspected Stone Event (SSE) category was created for participants with symptoms and passage without complete documentation. RESULTS: At time of this analysis 1532 participants were randomized with a median of 692 days of follow-up. Self-reported stone passage (n=185) was adjudicated by an independent committee as confirmed in 114 (61.6%), SSE in 61 (33%), and non-events in 10 (5.4%). The overall Kaplan Meier rate of confirmed plus suspected events at 1 year was 9.1% (95% CI 7.7-10.8). The rates of adjudicated stone passage varied across the duration of the study (Figure). CONCLUSIONS: In the PUSH trial rigorous blinded adjudication revealed that self-reported stone passage overwhelmingly represented definitive or likely (SSE) events at all time points up to 2 years. The divergence of the rate of confirmed vs suspected events after one year requires further investigation. The inclusion of SSE and procedural intervention allows for the full burden of stone events to be ascertained. These results will inform endpoint assessment in future urinary stone trials. Source of Funding: NIH/NIDDK © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e838 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hunter Wessells More articles by this author Henry Lai More articles by this author John Lieske More articles by this author Brian Matlaga More articles by this author Sharon Settles More articles by this author Hongqiu Yang More articles by this author Jonathan Harper More articles by this author Charles Scales More articles by this author Alana Desai More articles by this author Naim Maalouf More articles by this author Peter Reese More articles by this author Sri Sivalingam More articles by this author Gregory Tasian More articles by this author Hussein Al-Khalidi More articles by this author Ziya Kirkali More articles by this author Expand All Advertisement PDF downloadLoading ...