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

Vastra Gotaland Region

Status: Begins enrollment in 1 month

Conditions: Bladder Cancer; Hematuria; Renal Cancer; Urothelial Carcinoma; Acute Cystitis With Hematuria

Treatments: Procedure: investigation setting (cystoscopy + CTU + cytology)

Study type: Observational

Funder types: Other

Identifiers

NCT07037589

BLUSH trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 110 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

300 participants in 2 patient groups

AHG (Acute Hemorrhagic Cystitis Group):

Description:

Patients with acute onset macroscopic hematuria with lower urinary tract symptoms such as dysuria, frequency, and urgency of less than one week's duration.

Treatment:

Procedure: investigation setting (cystoscopy + CTU + cytology)

non AHG (non-Acute Hemorrhagic Cystitis Group):

Description:

Patients with atypical clinical presentation such as: Chronic irritative symptoms \>4 weeks. Recurrent UTI (≥2 episodes in 6 months or ≥3 episodes per year). Febrile UTI. Absence of irritative symptoms.

Treatment:

Procedure: investigation setting (cystoscopy + CTU + cytology)