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

NCT ID: NCT07037589

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2027-08-30

Brief 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.

Detailed Description

The BLUSH trial is a prospective, multicenter, observational study investigating whether full malignancy workup is necessary in women ≥50 years presenting with isolated acute hemorrhagic cystitis (AHC) and macroscopic hematuria. AHC is defined as macroscopic hematuria accompanied by acute lower urinary tract symptoms (dysuria, frequency, urgency) of less than one week's duration. Women with prior urological malignancies, significant comorbidities, or impaired consent capacity are excluded.

All enrolled patients undergo standardized initial assessment including full clinical history (smoking, family history, comorbidities), physical examination, urinalysis, urine culture, cystoscopy, CT urography, and cytology when indicated. Participants are stratified into AHC and non-AHC groups based on symptomatology and laboratory findings. Data collection includes demographics, symptom duration, urine findings, cancer diagnoses (type, stage, grade), treatment details, and clinical outcomes.

Patients are followed for a minimum of 12 months via medical record review to capture delayed cancer diagnoses. Data are pseudonymized and stored securely under GDPR regulations. The primary outcome is the incidence of urological malignancy within one year. Secondary outcomes include time to diagnosis, proportion of avoidable invasive procedures, and accuracy of the AHC classification in predicting cancer risk.

The study aims to support individualized risk-based management in women with hematuria.

Conditions

Hematuria; Acute Cystitis With Hematuria; Bladder Cancer; Urothelial Carcinoma; Renal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

investigation setting (cystoscopy + CTU + cytology)

Intervention Type: 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.

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.

Cystoscopy - CTU - cytology (if needed)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suleiman Abuhasanein

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg

Locations

Uddevalla Hospital

Uddevalla, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Suleiman Abuhasanein, PhD

Role: CONTACT

suleiman.abuhasanein@gu.se

0104353572

Facility Contacts

Abuhasanein

Role: primary

suleiman.abuhasanein@gu.se

0104353572

Other Identifiers

BLUSH trial

Identifier Type: -

Identifier Source: org_study_id