Acute Cystitis With Hematuria, Bladder Cancer, Hematuria, Renal Cancer, Urothelial Carcinoma
Conditions
Brief 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.
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.
Sponsors
Vastra Gotaland Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 110 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of urological malignancy | At least 12 months from study inclusion. | The proportion of women diagnosed with urological cancer (bladder, upper urinary tract, or kidney cancer) within 12 months after initial presentation of macroscopic hematuria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to cancer diagnosis | At least 12 months from study inclusion. | Duration from initial presentation to confirmed diagnosis of urological malignancy. |
| Proportion of potentially avoidable invasive procedures in AHG | At least 12 months from study inclusion. | Percentage of invasive diagnostic procedures (e.g., cystoscopy, CT-urography) in the Acute Hemorrhagic Cystitis Group (AHG) that could have been avoided based on study findings. |
| Sensitivity and specificity of AHC classification | At least 12 months from study inclusion. | Accuracy of the acute hemorrhagic cystitis (AHC) clinical classification in predicting urological malignancy, measured by sensitivity and specificity. |
Countries
Sweden
Contacts
Primary ContactSuleiman Abuhasanein, PhD
Outcome results
None listed