Do women over 50 with sudden bladder infection symptoms and visible blood in their urine need full cancer checks?
Official title: Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed? A Prospective Multicenter Study. BLUSH Trial
Run by Vastra Gotaland Region · NCT07037589 · Data updated 2026-11-12
This project will see if women 50 and older who have sudden visible blood in their urine with short-term bladder infection symptoms can safely avoid full cancer investigations.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 110 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Uddevalla) |
| Status | Recruiting |
| Started | October 13, 2025 |
| Main results expected | August 30, 2026 |
| Study ends | August 30, 2027 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07037589 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 50 or older presenting within one week with visible blood in the urine and acute lower urinary tract symptoms who can give informed consent and have no prior urologic malignancy.
✕Probably not a fit
Women with prior bladder, renal, or upper tract urothelial cancer, ongoing urologic cancer treatment, significant comorbidities, cognitive impairment, or pregnancy are excluded and would not benefit from this risk-stratified approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective multicenter observational study enrolls women aged 50 and older presenting with macroscopic hematuria and acute lower urinary tract symptoms of less than one week's duration. All participants receive a standardized initial assessment including history, urinalysis and culture, cystoscopy, CT urography, and cytology when indicated, and are stratified based on symptom and lab findings into AHC and non-AHC groups. Data on demographics, urine findings, cancer diagnoses, treatments, and outcomes are collected and patients are followed for at least 12 months to capture any delayed malignancy diagnoses. The primary outcome is the incidence of urological malignancy within one year, with secondary outcomes including time to diagnosis, potentially avoidable invasive procedures, and the accuracy of the AHC classification in predicting cancer risk.
Why it matters
Potential benefit: If successful, the approach could reduce unnecessary invasive testing, lowering patient burden, anxiety, and healthcare costs while focusing diagnostic resources on higher-risk patients.
How similar studies have gone: Previous observational analyses and guideline reviews have suggested a low cancer detection rate in women with acute cystitis–related hematuria, but prospective multicenter confirmation is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Uddevalla Hospital
Uddevalla, Sweden Recruiting
Study contacts
- Principal investigator: Suleiman Abuhasanein — Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg
- Study coordinator: Suleiman Abuhasanein, PhD
- Email: suleiman.abuhasanein@gu.se
- Phone: 0104353572
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.