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

Sponsor
Vastra Gotaland Region
Study ID
NCT07037589
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 110 Years
Healthy Volunteers
Accepted

Interventions

  • investigation setting (cystoscopy + CTU + cytology) — PROCEDURE
    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.
  • Cystoscopy - CTU - cytology (if needed) — PROCEDURE
    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.

Study Details

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 Dates

First listed
Jun 25, 2025
Start date
Oct 13, 2025
Status verified
Jun 2025
Primary completion
Aug 30, 2026
Completion
Aug 30, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: AHG (Acute Hemorrhagic Cystitis Group):
    Patients with acute onset macroscopic hematuria with lower urinary tract symptoms such as dysuria, frequency, and urgency of less than one week's duration.
  • Arm: non AHG (non-Acute Hemorrhagic Cystitis Group):
    Patients with atypical clinical presentation such as: Chronic irritative symptoms \>4 weeks. Recurrent UTI (≥2 episodes in 6 months or ≥3 episodes per year). Febrile UTI. Absence of irritative symptoms.

Primary Outcome Measure

Incidence of urological malignancy [ Time Frame: At least 12 months from study inclusion. ]

Central Contacts

Find similar trials

Nationwide
Bladder cancer trialsKidney cancer trialsOncology trialsUrology trials

Related Studies