Pd08-08 a Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria

You have accessJournal of UrologyHealth Services Research: Value of Care: Cost and Outcomes I (PD08)1 May 2024PD08-08 A MULTICENTER PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING CXBLADDER TRIAGE TO CYSTOSCOPY IN PATIENTS WITH MICROHEMATURIA Yair Lotan, Siamak Daneshmand, Neal Shore, Peter Black, Kristen Scarpato, Amit Patel, Tony Lough, Daniel Shoskes, and Jay Raman Yair LotanYair Lotan , Siamak DaneshmandSiamak Daneshmand , Neal ShoreNeal Shore , Peter BlackPeter Black , Kristen ScarpatoKristen Scarpato , Amit PatelAmit Patel , Tony LoughTony Lough , Daniel ShoskesDaniel Shoskes , and Jay RamanJay Raman View All Author Informationhttps://doi.org/10.1097/01.JU.0001008576.33217.96.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Current AUA guidelines for patients with microhematuria (≥ 3 RBC/hpf) include cystoscopy for the majority of patients over age 40 due to risk of urothelial cancer (UC) which ranges from 2-5%. Cxbladder Triage is an mRNA based urinary genomic test with a negative predictive value of 99% for UC. In this interim analysis of a prospective multicenter randomized controlled trial we compared use of cystoscopy in a standard of care arm versus a marker based approach. METHODS: Patients with asymptomatic microhematuria were enrolled into the trial and provided urine for a Cxbladder Triage test. Those categorized as "low risk" (LR) defined as≥3 to 29 RBC/hpf and minimal smoking history (0-10 pack years) were randomized 2:1 between the test group who were provided the Triage test result vs the standard of care (SOC) group (Cystoscopy). Those with a negative Triage were offered omission of cystoscopy with surveillance using marker, urine cytology and abdominal ultrasound. Patient decision and results of cystoscopy if done were recorded. RESULTS: Of 449 patients enrolled, 205 were LR and randomized to Triage informed decision (132) or SOC (73) and complete information was available in 147. The median age was 56 years (range 18-90) and 48% were male. In the SOC arm, 38/59 (64%) of patients had cystoscopy. In the Triage arm, 79/88 (90%) had a negative Triage test. Cystoscopy was chosen by 20/79 (25%) who had a negative test and 7/9 (78%) with a positive test. Overall the cystoscopy rate in the Triage group was 27/88 (31%) which was a 52% reduction compared to the SOC arm (chi2 16.3, p=0.00005). In those who had cystoscopy, 1 UC was found (patient had a positive Triage test). CONCLUSIONS: In this prospective multicenter randomized controlled trial, use of Cxbladder Triage to inform the decision for cystoscopy in patients with lower risk asymptomatic microscopic hematuria resulted in a 52% reduction in cystoscopy. This demonstrated clinical utility of Cxbladder Triage can help reduce the burden of unnecessary cystoscopies in this population resulting in less patient morbidity and discomfort, improved access to care, and reduced environmental impact. Download PPT Source of Funding: Pacific Edge Diagnostics © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e176 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Yair Lotan More articles by this author Siamak Daneshmand More articles by this author Neal Shore More articles by this author Peter Black More articles by this author Kristen Scarpato More articles by this author Amit Patel More articles by this author Tony Lough More articles by this author Daniel Shoskes More articles by this author Jay Raman More articles by this author Expand All Advertisement PDF downloadLoading ...