NCT07037589

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: Female
• Age: 18 Years – 110 Years
• Healthy volunteers: Accepted

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.

Detailed description

The BLUSH trial is a prospective, multicenter, observational study investigating whether full malignancy workup is necessary in women ≥50 years presenting with isolated acute hemorrhagic cystitis (AHC) and macroscopic hematuria. AHC is defined as macroscopic hematuria accompanied by acute lower urinary tract symptoms (dysuria, frequency, urgency) of less than one week's duration. Women with prior urological malignancies, significant comorbidities, or impaired consent capacity are excluded. All enrolled patients undergo standardized initial assessment including full clinical history (smoking, family history, comorbidities), physical examination, urinalysis, urine culture, cystoscopy, CT urography, and cytology when indicated. Participants are stratified into AHC and non-AHC groups based on symptomatology and laboratory findings. Data collection includes demographics, symptom duration, urine findings, cancer diagnoses (type, stage, grade), treatment details, and clinical outcomes. Patients are followed for a minimum of 12 months via medical record review to capture delayed cancer diagnoses. Data are pseudonymized and stored securely under GDPR regulations. The primary outcome is the incidence of urological malignancy within one year. Secondary outcomes include time to diagnosis, proportion of avoidable invasive procedures, and accuracy of the AHC classification in predicting cancer risk. The study aims to support individualized risk-based management in women with hematuria.

Conditions

• Hematuria
• Acute Cystitis With Hematuria
• Bladder Cancer
• Urothelial Carcinoma
• Renal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-13
• Primary completion: 2026-08-30
• Completion: 2027-08-30
• First posted: 2025-06-25
• Last updated: 2025-11-21

Locations

1 site across 1 country: Sweden