External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the CUETO Group

- Age >22.

- Patients with a history of non-muscle invasive bladder cancer (any risk group, any intravesical adjuvant treatment received) over the last 3 months to 2 years, initial or recurrent, undergoing regular cystoscopic surveillance. The criteria for cystoscope FU schedule has been already described in Methods following EAU 2022 Guidelines´ recommendations and related to initial NMIBC risk grouping.

- Patient must be able to provide at least 10 ml of urine.

- Additional 10 ml of urine needs to be collected for cytology.

- Patients must be able to provide informed consent 2.- Subgroup analysis (secondary Objective 1):

- Age >22

- Patients with a history of primary non-muscle invasive bladder cancer with presence of CIS over the last 3 months to 3 years, and previously treated with BCG undergoing regular cystoscopic surveillance.

- Patient must be able to provide at least 10 ml of urine.

- Additional 10 ml of urine needs to be collected for cytology.

- Patients must be able to provide informed consent. 3.- Subgroup analysis (secondary Objective 2):

- Age >22

- Patients included in both previous groups, having a positive Uromonitor® test and a negative cystoscopy to be followed by two years as previously described depending on initial NMIBC risk group. The rest of the patients will also be followed 2 years to detect later recurrences/progression figures.

- Patients who are unable to provide the minimum amount of urine needed to perform one test.

- Not possible to ascertain informative cystoscope due to intolerance to the procedure

- Presence of bladder stone

- Presence of entero-vesical fistulae

- Presence of vesico-vaginal fistulae

- Non informative cystoscope due to macroscopic haematuria or cloudy urine

- Other conditions avoiding a clear tumour rule-out cystoscope