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Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed?
RECRUITINGSponsored by Vastra Gotaland Region
Actively Recruiting
SponsorVastra Gotaland Region
Started2025-10-13
Est. completion2026-08-30
Eligibility
Age18 Years – 110 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07037589
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. The aim is to identify low-risk patients where invasive investigations may be safely avoided.
Eligibility
Age: 18 Years – 110 YearsSex: FEMALEHealthy volunteers accepted
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.
Conditions6
Acute Cystitis With HematuriaBladder CancerCancerHematuriaRenal CancerUrothelial Carcinoma
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Actively Recruiting
SponsorVastra Gotaland Region
Started2025-10-13
Est. completion2026-08-30
Eligibility
Age18 Years – 110 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07037589