Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed?

Condition(s) studied

Investigational drug(s) / intervention(s)

investigation setting (cystoscopy + CTU + cytology): Observational study. All patients in this group undergo standard diagnostic evaluation including cystoscopy, CT urography, and urine cytology (if clinically indicated), performed during initial assessment for acute macroscopic hematuria.

Cystoscopy - CTU - cytology (if needed): All patients in this group undergo standard diagnostic evaluation including cystoscopy, CT urography, and urine cytology (if clinically indicated), performed during initial assessment for atypical or chronic presentations of macroscopic hematuria.

Study summary

This prospective multicenter observational study evaluates whether women ≥50 years with isolated acute hemorrhagic cystitis (AHC) and macroscopic hematuria require full malignancy workup. All participants undergo standard diagnostics (cystoscopy, CT urography, cytology), with 12-month follow-up for cancer detection. The aim is to identify low-risk patients where invasive investigations may be safely avoided.

Eligibility

Primary outcome measure(s)

• Incidence of urological malignancy — At least 12 months from study inclusion.
  The proportion of women diagnosed with urological cancer (bladder, upper urinary tract, or kidney cancer) within 12 months after initial presentation of macroscopic hematuria.

Trial sites (1)

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