RecruitingNCT07037589

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

Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed? A Prospective Multicenter Study. BLUSH Trial


Sponsor

Vastra Gotaland Region

Enrollment

300 participants

Start Date

Oct 13, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 110 Years

Inclusion Criteria4

  • Women ≥50 years of age.
  • Macroscopic hematuria.
  • Presenting for evaluation within the SCP for macroscopic hematuria.
  • Ability to provide informed consent.

Exclusion Criteria5

  • Prior diagnosis of bladder cancer, renal cancer, or upper tract urothelial carcinoma (UTUC).
  • Cognitive impairment preventing informed consent.
  • Ongoing or recent treatment for urological malignancy.
  • Serious comorbidities affecting participation or safety.
  • Pregnant women.

Interventions

PROCEDUREinvestigation 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.

PROCEDURECystoscopy - 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.


Locations(1)

Uddevalla Hospital

Uddevalla, Sweden

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NCT07037589


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