The Simultaneous Use of Bladder Epicheck® and Urinary Cytology Can Improve the Sensitivity and Specificity of Diagnostic Follow-Up of Urothelial Lesions: Up-to-Date Data from a Multi-Institutional Cohort

Abstract

Background/Objectives: Bladder cancer is a prevalent urinary system malignancy and urinary cytology is widely used for its screening and follow-up. A novel diagnostic tool called Bladder Epicheck^® (BE) is increasingly being used for monitoring the recurrence of non-muscle-invasive bladder cancer (NMIBC). The simultaneous use of BE and urinary cytology can increase the diagnostic performances in the follow-up of bladder neoplasms. Methods: In this multicenter study, we retrospectively evaluated the data of 322 patients in follow-up for a high-grade bladder carcinoma over a six-year period (from January 2018 to March 2024). The diagnostic performances of both cytology and BE and their combination were calculated using histology as gold standard. Results: Recurrences were diagnosed as high-grade urothelial carcinoma NMIBC in 18 cases, low-grade papillary NMIBC in 8 cases, and carcinoma in situ (CIS) in 4 cases. Cytological analysis correctly identified 26 out of 30 carcinomas, while 286 were correctly diagnosed as negative results. BE correctly identified 25 out of 30 carcinomas, 285 were correctly diagnosed as negative results. The combination of BE and urinary cytology correctly identified 29 out of 30 carcinomas, while 289 were correctly diagnosed as negative results. Conclusions: The combination of BE and cytology could be the most effective approach for follow-up diagnosis in patients with high-grade NMIBC, reducing unnecessary invasive procedures.

Keywords: Bladder Epicheck®; bladder cancer; urinary cytology.

Figure 1

The figure illustrates the diagnostic accuracy of Bladder Epicheck^® (BE), cytology, and their combination. BE correctly identified 25 out of 30 carcinomas, while cytology accurately detected 26 out of 30. The combination of both techniques demonstrated the highest accuracy, correctly identifying 29 out of 30 carcinomas. In terms of negative results, BE correctly identified 285 out of 292 cases, cytology identified 286 out of 292 cases, and the combined approach identified 289 out of 292 cases (C + BE = cytology and Bladder Epicheck^®; C = cancer at recurrence; NC = no cancer at recurrence).

Figure 2

(a,b) show representative cytological aspects of neoplastic urothelial cells with divergent differentiation (squamous differentiation), with nuclear atypia and prominent nucleoli ((a,b): Papanicolaou stain, ×200). (c,d) show the corresponding histological features of high-grade urothelial carcinoma with divergent differentiation (squamous differentiation), made up of pleomorphic cells with marked nuclear atypia, prominent nucleoli, and an abundance of eosinophilic cytoplasms ((c): hematoxylin and eosin (H&E) stain, ×100; (d): H&E stain, ×400).