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

NCT07037589 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

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

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.

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Suleiman Abuhasanein · Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-13
Primary Completion
2026-08-30
Completion
2027-08-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07037589 on ClinicalTrials.gov