Multicenter clinical trial with medical device associated with a drug in an authorised therapeutic use for the treatment of CVNMI evaluating the efficacy and tolerability of the adyuvant treatment with EMDA-MMC versus standard BCG in patients with high grade CVNMI

Non-muscle invasive bladder cancer

5-year tumor recurrence rate. Defined as the percentage of pathologically confirmed urothelial carcinoma recurrences following transurethral resection (TUR) or biopsy, after a specified period of time during which the patient has remained disease-free. Recurrence rates will be compared between the two study groups.

Disease-free survival (DFS)., Tumor progression rate, defined as the percentage of patients who develop stage ≥ T2 disease., Tumor progression-free survival (PFS)., Overall survival., Adjuvant treatment completion rate., Cost-effectiveness evaluation of the use of the developed model for the follow-up of patients with high-grade NMIBC treated with adjuvant BCG or EMDA-MMC, Prospective and detailed recording of adverse events (AEs) and serious adverse events (SAEs)., Impact of adjuvant treatment on patient quality of life (FACT-BL, HADs, and Distress Thermometer).

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