Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test

Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)

The goal of this clinical study is to learn how well a urine test called Xpert® Bladder Cancer Detect (Xpert BC-D) can help doctors assess the risk of bladder cancer in people with non-visible blood in their urine (microscopic hematuria). The main questions it aims to answer are:

• Can the Xpert BC-D test accurately identify people at higher risk for bladder cancer?
• Can combining the test results with other clinical information improve risk assessment compared to standard evaluation methods?

Participants will:

• Have leftover urine from the routine initial evaluation tested with the Xpert® Bladder Cancer Detect assay
• Complete questionnaires about urinary symptoms using the modified IPSS and ICIQ-FLUT-S forms
• Attend a first visit for medical evaluation and cystoscopy
• Attend a follow-up visit 3 to 6 months later for additional testing and questionnaires

This study includes adults over 40 years of age who have had microscopic hematuria detected within the past six months. People with a history of bladder cancer, urinary tract surgery, or certain other medical conditions, as well as individuals who are currently pregnant, cannot participate.

The study will be conducted at 20-24 sites in Germany and Austria and will last approximately 27 months, with each participant involved for about 6 months. The results of this study may help doctors better decide which patients need further invasive testing, potentially reducing unnecessary procedures.

Inclusion Criteria:

• Signed consent form after being informed about the study
• Willing and able to follow the study requirements
• Non-visible blood in the urine, found within the past 6 months
• Age over 40 years

Exclusion Criteria:

• Previous diagnosis of bladder cancer
• Too much protein in the urine (shown by urine test)
• Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test)
• Current pain in the urinary tract or lower belly, pain score greater than 2 on a 0-10 scale
• Signs of kidney-related blood in the urine (found by special urine test)
• Bladder examination with a camera (cystoscopy) within the past 12 months
• Pregnancy
• Visible blood in the urine within the past year
• Previous surgery on the urinary tract
• Previous radiation treatment to the pelvic area
• Permanent tube or foreign body in the urinary tract (such as a catheter)
• Participation in another clinical study at the same time or within 30 days before this study
• Detained under legal or official authority
• Medical, psychological, or social problems that would make it hard to follow the study requirements
• Not able to understand the study information well enough to give consent