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.

Last updated: November 6, 2025
Sponsor: Pacific Edge Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephropathy

Bladder Cancer

Urothelial Cancer

Treatment

Cxbladder Triage Plus

Cxbladder Detect+

Clinical Study ID

NCT06394869
CXB/2024/CREDIBLE
  • Ages 18-88
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is referred for assessment of microhematuria (MH) with presentationconfirmed 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 beensurgically 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 istaking place to 88 years of age inclusive, at the time of signing the informedconsent.

  6. Ability to comprehend written and spoken English sufficiently to independentlyfollow all study procedures. Or ability to comprehend Spanish with access to anEnglish-Spanish interpreter for all study related verbal instructions anddiscussions.

Exclusion

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/orduring 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 prostatichyperplasia symptoms and desires a procedure, weak stream with concerns for urethralstricture).

  6. Cystoscopy contraindicated due to another condition or anatomy.

  7. History of pelvic radiation.

  8. Currently receiving systemic chemotherapy or has had systemic chemotherapy withinthe 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 Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Cxbladder Triage Plus
Phase:
Study Start date:
April 29, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Urology Centers of Alabama

    Homewood, Alabama 35209
    United States

    Site Not Available

  • Urology Associates of Mobile

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Urology Centers of Alabama

    Homewood 4067927, Alabama 4829764 35209
    United States

    Active - Recruiting

  • Urology Associates of Mobile

    Mobile 4076598, Alabama 4829764 36608
    United States

    Active - Recruiting

  • Advanced Urology Institute - Daytona Beach

    Daytona Beach 4152872, Florida 4155751 32114
    United States

    Active - Recruiting

  • Urologic Specialists of Northwest Indiana

    Merrillville 4923482, Indiana 4921868 46410
    United States

    Active - Recruiting

  • Southern Urology

    Lafayette 4330145, Louisiana 4331987 70508
    United States

    Active - Recruiting

  • Chesapeake Urology Research Associates

    Hanover, Maryland 21076
    United States

    Site Not Available

  • Chesapeake Urology Research Associates

    Hanover 4357340, Maryland 4361885 21076
    United States

    Active - Recruiting

  • Summit Health

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Summit Health

    Voorhees Township 5105860, New Jersey 5101760 08043
    United States

    Active - Recruiting

  • Albany MED Health System

    Albany, New York 12208
    United States

    Site Not Available

  • Premier Medical Group of the Hudson Valley, P. C.

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Albany MED Health System

    Albany 5106834, New York 5128638 12208
    United States

    Active - Recruiting

  • Integrated Medical Professionals

    New York 5128581, New York 5128638 11042
    United States

    Active - Recruiting

  • Premier Medical Group of the Hudson Valley, P. C.

    Poughkeepsie 5132143, New York 5128638 12601
    United States

    Active - Recruiting

  • Penn State Medical Center, Urology Research

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Penn State Medical Center, Urology Research

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Active - Recruiting

  • Urology Associates, P. C.

    Nashville, Tennessee 37209
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Urology Associates, P. C.

    Nashville 4644585, Tennessee 4662168 37209
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin-Madison

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Active - Recruiting

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