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RECRUITING
NCT07037589

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

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 110 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-10-13

Completion Date

2027-08-30

Last Updated

2025-11-21

Healthy Volunteers

Yes

Interventions

PROCEDURE

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.

PROCEDURE

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.

Locations (1)

Uddevalla Hospital

Uddevalla, Sweden