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
Qualifiers
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 design
Treatments tested in this trial
- investigation setting (cystoscopy + CTU + cytology)
- Cystoscopy - CTU - cytology (if needed)
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov