Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-110
SponsorVastra Gotaland Region
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women ≥50 years of age.
Macroscopic hematuria.
Presenting for evaluation within the SCP for macroscopic hematuria.
Ability to provide informed consent.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
investigation setting (cystoscopy + CTU + cytology)
Procedure/SurgeryObservational 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/SurgeryAll 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: AHG (Acute Hemorrhagic Cystitis Group):1 intervention
Group B: non AHG (non-Acute Hemorrhagic Cystitis Group):1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At least 12 months from study inclusion.Secondary outcomes
1
Time to cancer diagnosis
Duration from initial presentation to confirmed diagnosis of urological malignancy.
Time frame
At least 12 months from study inclusion.2
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.
Time frame
At least 12 months from study inclusion.3
Sensitivity and specificity of AHC classification
Accuracy of the acute hemorrhagic cystitis (AHC) clinical classification in predicting urological malignancy, measured by sensitivity and specificity.
Time frame
At least 12 months from study inclusion.Sponsors and contacts
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Source ClinicalTrials.gov