The role of URO17® in diagnosis and follow up of bladder cancer patients

Mohamed Ibrahim, Joshua Rabinowitz, Rebecca Hilbert, Aruni Ghose, Samita Agarwal, Rajiv Swamy, Ismail Bulut, Mirian Guttierrez, Ebtisam Buali, Ekram Nassar, Parag Jhavar, Fatima Al-Hashimi, Nikhil Vasdev

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Objective: to evaluate the role of urinary URO17® biomarker in the detection of urothelial tumors in haematuria patients and the detection of recurrence in non-muscle invasive bladder urothelial tumors. Materials and methods: Our study was formed of two cohorts of patients, group I represents patients presenting with haematuria (n = 98), while group II represents patients with known non-muscle invasive bladder cancers on their scheduled follow up cystoscopic investigation (n = 51). For both groups, patients were asked to provide urine samples before cystoscopy, either primary as part of the haematuria investigation or as a scheduled follow-up. Urine samples were sent anonymously for standard urine cytology and URO17® biomarker immunostaining. Results were compared to cystoscopic findings using Chi-square analysis and Fisher’s exact test (P < 0.05). Results: Group I was formed of 98 patients, with an average age of 60 years. URO17® showed 100% sensitivity and 96.15% specificity with a negative predictive value (NPV) of 100 and a positive predictive value (PPV) of 95.83. The results showed statistical significance with P value < 0.001. Group II was formed of 51 patients, with an average age of 75 years. URO17® was shown to have a sensitivity of 85.71% and NPV of 95.45. Eleven patients of group II were on scheduled BacillusCalmette-Guerin (BCG) and another 5 received Mitomycin C (MMC). The overall results of both groups combined (n = 149) showed statistical significance between flexible cystoscopy results and the results of urinary URO17® and urine cytology. Conclusion: URO17® has a potential to be a reliable test for diagnosis and follow up of urothelial cancer patients and a screening tool adjunct to flexible cystoscopy. Trial Registration: Not applicable as the current study is not a clinical trial, as per according to the National Institutes of Health, “studies that involve a comparison of methods and that do not evaluate the effect of the interventions on the participant do not meet the NIH clinical trial definition.”

Original languageEnglish
Article number34
Pages (from-to)1-7
Number of pages7
JournalBMC Urology
Issue number1
Early online date9 Feb 2024
Publication statusE-pub ahead of print - 9 Feb 2024


  • Bladder cancer
  • Non-muscle invasive tumor
  • URO17®
  • Urothelial cancer
  • cancer follow-up
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Cystoscopy
  • Urinary Bladder Neoplasms/pathology
  • Hematuria/diagnosis
  • Biomarkers
  • Urinary Bladder/pathology
  • Aged
  • Neoplasm Recurrence, Local/diagnosis


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