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Improving long-term monitoring in NMIBC: Digital Uromonitor® (dUM) as a complementary tool to cystoscopy for two-year
J Rubio-Briones1, F Guerrero Ramos2, A Mercadé Sánchez3
1Urología, Hospital VITHAS 9 de Octubre, Valencia, Spain.
Objective:
Non-muscle-invasive bladder cancer (NMIBC) has a high risk of recurrence and requires intensive long-term surveillance. Existing clinical risk models offer limited prognostic accuracy. Molecular urine-based assays may improve prognostic assessment accuracy of future recurrence. This study evaluated whether Digital Uromonitor® (dUM), detecting TERT and FGFR3 mutations via ddPCR, enhances prognostic assessment of two-year recurrence beyond cystoscopy and cytology in a prospective multicenter cohort.
Methods:
This prospective, multicenter observational study (EVALUATION-CUETO; NCT05864599) enrolled consecutive NMIBC patients from 26 institutions. Eligible participants had an index tumor diagnosed 3 months-2 years before recruitment and completed two years of follow-up with sufficient DNA for dUM analysis. Clinical, pathological, and biomarker variables (cystoscopy, cytology, dUM) were collected. Recurrence rate was defined as events per year and classified as high (R > 0.5) or low (R ≤ 0.5).
Results:
Of 201 included patients, 75 (37%) were dUM-positive; TERT promoter mutations accounted for 88% of these cases. dUM showed prognostic value, correctly identifying 59% of recurrences over two years of standardized FU, outperforming cystoscopy alone (42%), with specificity of 74% and NPV of 78%. Combining dUM with cystoscopy increased sensitivity to 71%. Patients negative for both cystoscopy and TERT had the lowest recurrence risk (14%), whereas dual-positive patients exceeded 80%. High baseline recurrence rate consistently increased risk across all biomarker categories.
Conclusions:
dUM provides robust, reproducible prognostic information and significantly improves molecular risk stratification in NMIBC. These findings support its potential integration into risk-adapted surveillance strategies, pending validation in larger populations.
