Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Cystitis With Hematuria | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Hematuria | — | UNRESOLVED | — |
| Renal Cancer | — | UNRESOLVED | — |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cystoscopy - CTU - cytology (if needed) | Procedure | — | UNRESOLVED |
| investigation setting (cystoscopy + CTU + cytology) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Procedure: investigation setting (cystoscopy + CTU + cytology)
- label
- 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.
- interventionNames
- Procedure: Cystoscopy - CTU - cytology (if needed)
Primary outcomes (1)
- measure
- Incidence of urological malignancy
- timeFrame
- At least 12 months from study inclusion.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available