Urinary Biomarkers: Is the Era of Exclusive Follow-Up Cystoscopy Coming to an End? A Mini-Review of Emerging Molecular Diagnostics and Risk-Stratified Surveillance

Abstract

Bladder cancer is among the most costly malignancies to treat, primarily due to the high rate of recurrence for Non-Muscle-Invasive Bladder Cancer (NMIBC) and the subsequent necessity for lifelong cystoscopic surveillance. Although cystoscopy is widely regarded as the gold standard, it is an invasive procedure that can be costly and is associated with patient discomfort and anxiety. In recent years, a novel generation of urinary biomarkers (comprising genomic, epigenomic, and proteomic assays) has emerged, exhibiting diagnostic capabilities that increasingly challenge the prevailing role of cystoscopy in surveillance protocols. This mini-review examines the landscape of FDA-approved and emerging urinary biomarkers, compares their diagnostic accuracy, evaluates the first randomized controlled trials supporting biomarker-guided surveillance, and proposes a risk-stratified algorithm for the future integration of urinary biomarkers into clinical practice.