HematuriaBLUSHNCT07037589
Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed?
An observational study of Hematuria and Acute Cystitis With Hematuria, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hematuria, Acute Cystitis With Hematuria, Bladder Cancer
- What is being tested?
- investigation setting (cystoscopy + CTU + cytology) and Cystoscopy - CTU - cytology (if needed)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 13 Oct 2025to 30 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women aged 50 years and older presenting with macroscopic hematuria. Participants are recruited at initial presentation within the standard care pathway for hematuria evaluation at participating centers in Sweden.
Who may be able to join
- Women ≥50 years of age.
- Macroscopic hematuria.
- Presenting for evaluation within the SCP for macroscopic hematuria.
- Ability to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uddevalla Hospital
Uddevalla, 45 198
Abuhasanein, 0104353572, suleiman.abuhasanein@gu.se
About this study
Official title: Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed? A Prospective Multicenter Study. BLUSH Trial
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.
Read the 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.
- Conditions
- Hematuria, Acute Cystitis With Hematuria, Bladder Cancer, Urothelial Carcinoma, Renal Cancer
- Being tested
- investigation setting (cystoscopy + CTU + cytology), Cystoscopy - CTU - cytology (if needed)
- Medical subject headings
- Hematuria, Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigation setting (cystoscopy + CTU + cytology)Procedure or surgery
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.
Cystoscopy - CTU - cytology (if needed)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| AHG (Acute Hemorrhagic Cystitis Group): | Patients with acute onset macroscopic hematuria with lower urinary tract symptoms such as dysuria, frequency, and urgency of less than one week's duration. Receives: Procedure: investigation setting (cystoscopy + CTU + cytology) | |
| non AHG (non-Acute Hemorrhagic Cystitis Group): | 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. Receives: Procedure: Cystoscopy - CTU - cytology (if needed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of urological malignancy
The proportion of women diagnosed with urological cancer (bladder, upper urinary tract, or kidney cancer) within 12 months after initial presentation of macroscopic hematuria.
Measured: At least 12 months from study inclusion.
Secondary outcomes (3)
Time to cancer diagnosis
Duration from initial presentation to confirmed diagnosis of urological malignancy.
Measured: At least 12 months from study inclusion.
Proportion of potentially avoidable invasive procedures in AHG
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.
Measured: At least 12 months from study inclusion.
Sensitivity and specificity of AHC classification
Accuracy of the acute hemorrhagic cystitis (AHC) clinical classification in predicting urological malignancy, measured by sensitivity and specificity.
Measured: At least 12 months from study inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start13 Oct 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Suleiman Abuhasanein, Principal investigator, Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037589
- Sponsor's protocol ID
- BLUSH trial
- Acronym
- BLUSH
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, no final decision has been made regarding sharing of individual participant data (IPD). Any future sharing would require appropriate ethical approvals, participant consent, and compliance with data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed? A Prospective Multicenter Study. BLUSH Trial
- ClinicalTrials.gov ID
- NCT07037589
- Acronym / sponsor ID
- BLUSH / BLUSH trial
- Conditions
- Hematuria, Acute Cystitis With Hematuria, Bladder Cancer, Urothelial Carcinoma, Renal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AHG (Acute Hemorrhagic Cystitis Group): | – | Procedure: investigation setting (cystoscopy + CTU + cytology)Patients with acute onset macroscopic hematuria with lower urinary tract symptoms such as dysuria, frequency, and urgency of less than one week's duration. |
| non AHG (non-Acute Hemorrhagic Cystitis Group): | – | Procedure: Cystoscopy - CTU - cytology (if needed)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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 50 years and older presenting with macroscopic hematuria. Participants are recruited at initial presentation within the standard care pathway for hematuria evaluation at participating centers in Sweden.
Key inclusion criteria (4 listed)
- Women ≥50 years of age.
- Macroscopic hematuria.
- Presenting for evaluation within the SCP for macroscopic hematuria.
- Ability to provide informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | AHG (Acute Hemorrhagic Cystitis Group): |
| 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. | Procedure or surgery | non AHG (non-Acute Hemorrhagic Cystitis Group): |
Primary outcome
Incidence of urological malignancy
Time frame: 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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided. At this time, no final decision has been made regarding sharing of individual participant data (IPD). Any future sharing would require appropriate ethical approvals, participant consent, and compliance with data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suleiman Abuhasanein principal investigator
Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematuria and Acute Cystitis With Hematuria, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suleiman Abuhasanein, PhD (0104353572, suleiman.abuhasanein@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of urological malignancy (time frame: At least 12 months from study inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.