White light cystoscopy (WLC) misses ∼70% of carcinoma in situ bladder recurrences that could be identified via photodynamic diagnosis (PDD). The Bladder EpiCheck (BE) test has high sensitivity and specificity, with a recognised anticipatory positive signal. Our aim was to determine the diagnostic accuracy of BE and WLC against PDD-guided biopsy as the diagnostic benchmark during surveillance for high-grade (HG) non-muscle-invasive bladder cancer (NMIBC).
As part of a National Health Service (NHS) quality improvement project, all consecutive patients with HG-NMIBC who were fit for general anaesthesia and on surveillance in a tertiary centre underwent both WLC and BE from July 2023 to August 2024. Data were prospectively collected. Voided urine was collected before WLC for BE testing. Positive WLC and/or BE results triggered PDD-guided biopsy/resection under general anaesthesia. Performance metrics for WLC and BE were calculated on the basis of biopsies performed within 6 mo of a surveillance visit.
Valid BE results were available for 315 HG-NMIBC surveillance visits. Of the 37 pathologically confirmed recurrences, 23 (62%, 95% confidence interval [CI] 46-76%) were detected by WLC and 34 (92%, 95% CI 79-97%) by BE (p = 0.0074). Of the 30 HG recurrences, 19 (63%, 95% CI 46-78%) were detected by WLC and 27 (90%, 95% CI 74-97%) by BE (p = 0.0386). Most of the HG cancers missed by WLC and detected by BE (73%) were Tis. Performing PDD-guided biopsies for patients with negative WLC and positive BE results increased the BE specificity from 87% (95% CI 82-90%) to 93% (95% CI 89-96%), and the positive predictive value from 35% (95% CI 24-48%) to 57% (95% CI 44-68%) at 6 mo, and to 70% (95% CI 58-80%) at longer-term follow-up. The main limitations are the nonrandomised setting and the lack of a control group.
BE addition to WLC, with PDD-guided biopsy performed for BE-positive cases, reveals the true performance of BE and WLC and significantly improves the detection of HG disease, allowing earlier intervention with potentially bladder-sparing options.
European urology oncology. 2025 Nov 27 [Epub ahead of print]
Paramananthan Mariappan, Jasmin Hart-Brooke, Rebecca Sparks, Tanya Lord-McKenzie
Edinburgh Bladder Cancer Surgery, Department of Urology, Western General Hospital, Edinburgh, UK; The University of Edinburgh, Edinburgh, UK. Electronic address: ., Edinburgh Bladder Cancer Surgery, Department of Urology, Western General Hospital, Edinburgh, UK; Edinburgh Medical School, The University of Edinburgh, Edinburgh, UK., Edinburgh Medical School, The University of Edinburgh, Edinburgh, UK., Edinburgh Bladder Cancer Surgery, Department of Urology, Western General Hospital, Edinburgh, UK.