Women With isoLated acUte cyStitis and Macroscopic Hematuria. Is Further Investigation Needed?

Recruiting now

Conditions studied: Hematuria, Acute Cystitis With Hematuria, Bladder Cancer, Urothelial Carcinoma, Renal Cancer

In brief

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.

Key facts

Study ID

NCT07037589

Run by

Vastra Gotaland Region

People needed

300

Starts

2025-10-13

Expected to finish

2027-08-30

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older, up to 110. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women ≥50 years of age.
• Macroscopic hematuria.
• Presenting for evaluation within the SCP for macroscopic hematuria.
• Ability to provide informed consent.

You may not qualify if…

• 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.

Where it is running

• Uddevalla Hospital — Uddevalla, Sweden (enrolling)

Full record on ClinicalTrials.gov

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