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Search / Trial NCT07037589

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

Launched by VASTRA GOTALAND REGION · Jun 16, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at women aged 50 and older who have sudden blood in their urine caused by a bladder infection, a condition called acute hemorrhagic cystitis. The study wants to find out if these women really need to go through extensive and sometimes uncomfortable tests to check for serious illnesses like bladder or kidney cancer. By carefully watching these patients for a year and performing standard tests such as looking inside the bladder with a small camera (cystoscopy), imaging scans (CT urography), and urine tests, researchers hope to identify which women are at low risk and might safely avoid invasive investigations.

Women who have visible blood in their urine and are 50 years or older may be eligible to join, as long as they have not had bladder or kidney cancer before and are able to give consent. Participants will undergo the usual diagnostic procedures and will be followed for 12 months to see if any cancers develop. This study is important because it could help reduce unnecessary testing and stress for many women while still ensuring that serious illnesses are not missed.

Gender

FEMALE

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.

About Vastra Gotaland Region

Vastra Gotaland Region is a prominent healthcare organization in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. As a sponsor, the region leverages its extensive network of hospitals and healthcare professionals to facilitate high-quality research initiatives that address pressing health challenges. With a commitment to ethical standards and patient safety, Vastra Gotaland Region strives to foster collaboration between researchers, clinicians, and patients, ensuring that clinical trials contribute valuable insights and advancements in medical science.

Locations

Patients applied

0 patients applied

Trial Officials

Suleiman Abuhasanein

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported