Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.

Launched by PACIFIC EDGE LIMITED · Apr 28, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a new urine test called "Cxbladder Triage Plus" to see if it can reduce the number of cystoscopies—procedures where a small camera is inserted into the bladder to check for problems—in adults who have small amounts of blood in their urine that can only be seen under a microscope, a condition known as microhematuria. While blood in the urine can be concerning, especially because it might indicate bladder cancer, most patients do not have this condition. The trial will help determine if the results of the Triage Plus test can guide doctors and patients in deciding whether a cystoscopy is necessary.

To participate, individuals must be between 18 and 88 years old and have been referred to a urologist for assessment of microhematuria, with a confirmed presence of blood in their urine. Participants will provide a urine sample for the Triage Plus test and will then be randomly assigned to one of two groups. In one group, doctors will have access to the test results and can use them to help decide on the next steps. In the other group, standard care will be followed without considering the test results. Throughout the study, participants will be monitored for about nine months, and their experiences and decisions regarding cystoscopy will be documented. This trial is important as it may help reduce unnecessary procedures and make patient care more comfortable.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is referred for assessment of microhematuria (MH) with presentation confirmed by urine microscopy of 3 or more red blood cells per high powered field (RBC/HPF) (documented by the referring physician or at the investigator site) within 90 days of enrollment.
• • 2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered.
• • 3. Able to give informed, written consent.
• • 4. Able and willing to comply with study requirements.
• • 5. Aged 18 to 88 years.
• • 6. Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend Spanish with access to an English-Spanish interpreter for all study related verbal instructions and discussions.
• Exclusion Criteria:
• • 1. Prior history of bladder malignancy.
• • 2. Prior history of upper tract UC or prostatic urethral UC.
• • 3. Gross hematuria within the last six months (reported in patient's records and/or during patient's interview)
• • 4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
• • 5. Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture).
• • 6. Cystoscopy contraindicated due to another condition or anatomy.
• • 7. History of pelvic radiation.
• • 8. Currently receiving chemotherapy or has had chemotherapy within the last 6 weeks.
• • 9. History of schistosomiasis.
• • 10. History of chronic (\>3 months) indwelling Foley catheter or chronic (\>3 months) bladder stones.
• • 11. Known current pregnancy