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

Urothelial Carcinoma Bladder Cancer Renal Cancer Hematuria Acute Cystitis With Hematuria

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

Plain Language Summary

Simplified for easier understanding

This study looks at whether women aged 50 and over who have visible blood in their urine (macroscopic hematuria) due only to a urinary tract infection (cystitis) actually need further testing to rule out bladder or kidney cancer. **You may be eligible if...** - You are a woman aged 50 years or older - You have visible blood in your urine - You are being evaluated through a hematuria (blood in urine) clinic or pathway - You can provide informed consent **You may NOT be eligible if...** - You have a previous diagnosis of bladder cancer, kidney cancer, or upper urinary tract cancer - Your hematuria has causes other than an isolated urinary tract infection - You are unable to attend follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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