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Assessing a urine test to reduce cystoscopies for patients with microscopic blood in urine

Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)

Not applicable Interventional Pacific Edge Limited · NCT06394869

This study is testing a new urine test to see if it can help patients with tiny amounts of blood in their urine avoid unnecessary bladder scope procedures.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years to 88 Years
SexAll
SponsorPacific Edge Limited Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations15 sites (Homewood, Alabama and 14 other locations)
Trial IDNCT06394869 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Cxbladder Triage Plus urine test in reducing the number of cystoscopies performed on patients with microhematuria, which is the presence of small amounts of blood in urine that can only be detected microscopically. Patients referred to urologists for this condition will be assessed to determine if the urine test can help identify those who may not need invasive cystoscopy procedures. The study aims to improve patient comfort and reduce anxiety associated with cystoscopy while ensuring that bladder cancer is not overlooked. Participants must provide a urine sample and meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 88 who have been referred for assessment of microhematuria confirmed by urine microscopy.

Not a fit: Patients with a prior history of bladder malignancy or those experiencing gross hematuria within the last six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the number of unnecessary cystoscopies, minimizing patient discomfort and anxiety.

How similar studies have performed: While the specific approach of using Cxbladder Triage Plus is novel, similar urine tests have shown promise in reducing invasive procedures in other contexts.

Eligibility criteria

Show full inclusion / exclusion 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 6-months 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. Must be 19 or the legal age of consent in the jurisdiction in which the study is taking place to 88 years of age inclusive, at the time of signing the informed consent.
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 twelve 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 systemic chemotherapy or has had systemic 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

Where this trial is running

Homewood, Alabama and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hematuria - Cause Not Knownmicroscopic hematuriamicrohematuriaurothelial carcinomabladder cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.