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

Inclusion Criteria:

Main Outcome:

* 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.

Exclusion Criteria:

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

  * Patients planning to undergo radical cystectomy or chemotherapy, radiation for UC
  * Patients at risk for non-definitive information derived from the cystoscope due to different conditions:
* 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