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. (CREDIBLE)

November 6, 2025 updated by: Pacific Edge Limited

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

This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest worries, it is only found in few of these patients.

Most microhematuria patients will have a cystoscopy to look inside the bladder. During a cystoscopy, a small camera is inserted into the bladder. This is done through the urethra, the tube that passes urine from the bladder to the outside. In some patients it can cause pain or anxiety. Not all patients have a cystoscopy. Those that don't, usually return for a urine sample within 6 months. This is done to check if there is still blood in their urine.

This study is conducted to find out if the use of "Cxbladder Triage Plus" changes the number of cystoscopies in microhematuria patients. Cxbladder Triage Plus is also called "Triage Plus". It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder. Urothelial carcinoma is by far the most common type of bladder cancer. For the test, the patient voids some urine into a cup. A laboratory then checks the urine of specific genetic material. Abnormalities can be a sign of urothelial carcinoma. The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients.

The study is done to find out how Triage Plus changes the number of cystoscopies. Study participants first void urine into a cup. The urine is used for the Triage Plus test. The patients are then assigned to one of two groups. The assignment is random. This means the nobody can influence the assignment. The chance to be assigned to either group is the same. In the test group, the urologist will receive the Triage Plus result and discuss it with the patient. Together they decide whether to do a cystoscopy. In the control group, the urologist will not receive the Triage Plus result. The patient will also not get the result. The urologist and patient will follow standard of care to decide whether to do a cystoscopy.

For test group patients, the study gives a recommendation whether to proceed with cystoscopy. It is based on the patient's Triage Plus result. The urologist and patient do not need to follow the recommendation. If the urologist does not follow it, they will complete a survey. The survey has only one question. It is asking for the reasons of the decision.

After making their decision, patients will follow the chosen pathway. Data on the performed procedures are collected. The diagnosis will also be documented. Data will be collected for up to about 9 months.

To see how Triage Plus changes the number of cystoscopies, these will be counted in each group and then compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Recruiting
        • Urology Centers of Alabama
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Strang, MD
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Urology Associates of Mobile
        • Principal Investigator:
          • Charles F White, MD
        • Contact:
        • Contact:
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Recruiting
        • Advanced Urology Institute - Daytona Beach
        • Principal Investigator:
          • Samuel Lawindy, MD
        • Contact:
    • Indiana
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Southern Urology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thad Bourque, MD
    • Maryland
      • Hanover, Maryland, United States, 21076
        • Recruiting
        • Chesapeake Urology Research Associates
        • Contact:
        • Principal Investigator:
          • Rian J Dickstein, MD
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043
        • Recruiting
        • Summit Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gordon A Brown, DO, BA
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany MED Health System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adrien N Bernstein, MD
      • New York, New York, United States, 11042
        • Recruiting
        • Integrated Medical Professionals
        • Principal Investigator:
          • Jed Kaminetsky, MD
        • Contact:
      • Poughkeepsie, New York, United States, 12601
        • Recruiting
        • Premier Medical Group of the Hudson Valley, P. C.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Evan R Goldfischer, MD, FACS, CPE, CPI, MBA
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Medical Center, Urology Research
        • Contact:
        • Principal Investigator:
          • Jay D Raman, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Kristen R Scarpato, MD
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates, P. C.
        • Principal Investigator:
          • Gautam Jayram, MD
        • Contact:
        • Contact:
    • Texas
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin-Madison
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kyle Richards

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Arm
The site will receive the Cxbladder Detect+ result and the urologist study investigator discuss it with the patient before making a shared decision whether or not to proceed with cystoscopy.
Diagnostic test: Cxbladder Triage Plus
Cxbladder Triage Plus is a lab developed, test that is using RNA and DNA biomarkers in the urine to assess the likelihood of the presence of urothelial carcinoma in the bladder.
No Intervention: Control arm
Neither the site nor the patient will receive the Cxbladder Detect+ result. The decision whether or not to proceed with cystoscopy will be made following standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cystoscopy rate
Time Frame: 3 months from the decision to perform or not perform cystoscopy.
Difference in the proportion of cystoscopies performed in each arm.
3 months from the decision to perform or not perform cystoscopy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of imaging procedures
Time Frame: 3 months from the decision to perform or not perform cystoscopy.
Sub-analyses on AUA risk categories for primary and secondary objectives
3 months from the decision to perform or not perform cystoscopy.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of urothelial carcinoma (UC)
Time Frame: At the end of the current investigation, i.e. when a diagnosis was made or it was decided not to perform diagnostic procedures other than surveillance. Expected within approximately 120 days after sampling.
Difference in the proportion of UCs found in each arm.
At the end of the current investigation, i.e. when a diagnosis was made or it was decided not to perform diagnostic procedures other than surveillance. Expected within approximately 120 days after sampling.
Persistent hematuria.
Time Frame: At urinalysis 90-180 days (of the decision to proceed with surveillance)
Rate of persistent hematuria in patients choosing surveillance.
At urinalysis 90-180 days (of the decision to proceed with surveillance)
Physician rationale
Time Frame: After reviewing the Detect+ result and giving their recommendation, before cystoscopy (if applicable). Expected once and within 90 days of sampling
Physician-reported reasons for not following the study recommended pathway based on the Detect+ result.
After reviewing the Detect+ result and giving their recommendation, before cystoscopy (if applicable). Expected once and within 90 days of sampling
Patient rationale
Time Frame: After discussing the Detect+ result with the investigator, before cystoscopy (if applicable). Expected once and within 90 days of sampling .
Patient-reported reasons for not following the investigator recommended pathway.
After discussing the Detect+ result with the investigator, before cystoscopy (if applicable). Expected once and within 90 days of sampling .
Cxbladder Triage Plus performance and test negative rate.
Time Frame: At the end of the current investigation, i.e. when a diagnosis was made.
Number of false positive, true positive, false negative and true negative test results when comparing the Triage Plus result to the results of histopathologically confirmed cystoscopy.
At the end of the current investigation, i.e. when a diagnosis was made.
Imaging Rates
Time Frame: 3-months prior to 6-months post enrollment
Change in imaging rates between arms
3-months prior to 6-months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Edge Limited

Investigators

  • Study Chair: Tony Lough, PhD, Pacific Edge Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

April 28, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXB/2024/CREDIBLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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