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Recruiting NCT07037589

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

— Observational Hematuria Acute Cystitis With Hematuria Bladder Cancer Urothelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: investigation setting (cystoscopy + CTU + cytology), Cystoscopy - CTU - cytology (if needed).
Who it may be relevant to
Registry conditions: Hematuria, Acute Cystitis With Hematuria, Bladder Cancer, Urothelial Carcinoma. Basic parameters: 18 years — 110 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Incidence of urological malignancy [Time frame: At least 12 months from study inclusion.]
Secondary outcome measures (3)
  • Time to cancer diagnosis [Time frame: At least 12 months from study inclusion.]
  • Proportion of potentially avoidable invasive procedures in AHG [Time frame: At least 12 months from study inclusion.]
  • Sensitivity and specificity of AHC classification [Time frame: At least 12 months from study inclusion.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Uddevalla Hospital — Uddevalla

Identifiers

NCT: NCT07037589 · BLUSH trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗