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

NCT07037589 | Recruiting

• 1 other identifier: BLUSH trial
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of urological malignancy

  The proportion of women diagnosed with urological cancer (bladder, upper urinary tract, or kidney cancer) within 12 months after initial presentation of macroscopic hematuria.

  At least 12 months from study inclusion.

Secondary Outcomes (3)

• Time to cancer diagnosis

  At least 12 months from study inclusion.

• Proportion of potentially avoidable invasive procedures in AHG

  At least 12 months from study inclusion.

• Sensitivity and specificity of AHC classification

  At least 12 months from study inclusion.

Study Arms (2)

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.

Procedure: investigation setting (cystoscopy + CTU + cytology)

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.

Procedure: Cystoscopy - CTU - cytology (if needed)

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.

AHG (Acute Hemorrhagic Cystitis Group):

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.

non AHG (non-Acute Hemorrhagic Cystitis Group):

Eligibility Criteria

• Age: 18 Years - 110 Years
• Gender Eligibility Details: Eligibility is limited to individuals identifying as female, based on self-reported gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 50 years and older presenting with macroscopic hematuria. Participants are recruited at initial presentation within the standard care pathway for hematuria evaluation at participating centers in Sweden.

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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Uddevalla Hospital

Uddevalla, 45 198, Sweden

RECRUITING

MeSH Terms

Conditions

Hematuria; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms

Interventions

Cystoscopy; Cytological Techniques

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Suleiman Abuhasanein

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suleiman Abuhasanein, PhD

CONTACT

0104353572; suleiman.abuhasanein@gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-06

Locations

SE (1)