Tests a urine check to help decide on bladder camera exams in adults
Tests a urine test to guide bladder camera checks in adults with hidden blood.
Key facts
- Who runs it
- Pacific Edge Limited
- Where
- Albany, Austin, Dallas, Dayton, Daytona Beach, Fresno, Hanover, Hershey, Homewood, Lafayette, Los Angeles, Madison, Merrillville, Mobile, Nashville, New York, Poughkeepsie, and Voorhees Township, United StatesSee the 20 sites
- Trial code
- Registry title
- 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.
- Status
- Recruiting
- People taking part
- 1,000 people, planned
- Started
- 29 Apr 2025
- Expected to end
- Apr 2028
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Cxbladder Triage Plus
- Record updated
- 2 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults sent to a urologist because of microscopic blood in the urine. It tests whether a urine test called Cxbladder Triage Plus changes how many cystoscopies are done.
- Age
- 19 (or the legal age of consent where the study takes place) to 88 years
- Sex
- All sexes can join.
- Disease stage
- Recent blood in the urine: microscopic blood (3 or more red cells per high-power field on urine microscopy within 180 days before enrolment), or blood found by dipstick (2+ or more) and confirmed the same day.
- Earlier treatment
- No bladder cancer before. No systemic chemotherapy now or in the last 6 weeks. No pelvic radiation.
Main reasons for not taking part
- Earlier bladder cancer, or cancer of the upper urinary tract or the urethra in the prostate
- Visible blood in the urine in the last 12 months that needed a procedure or hospital stay
- Bladder that was rebuilt or diverted
- A reason for cystoscopy other than microscopic blood in the urine
- Known current pregnancy
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Patient is referred for assessment of recent hematuria, defined as either:; Microscopic hematuria (≥3 RBC/HPF or equivalent) on urine microscopy obtained within 180 days prior to enrollment, OR; Hematuria detected by dipstick analysis (≥2+ blood or equivalent) at referral and confirmed on the same calendar day and prior to enrollment, with urine microscopy collected on the same day as enrollment
- Physically able to provide a voided urine sample from a bladder that has not been surgically altered
- Able to give informed, written consent
- Able and willing to comply with study requirements
- 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
- 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
Who cannot take part
- Prior history of bladder malignancy
- Prior history of upper tract UC or prostatic urethral UC
- Currently receiving systemic chemotherapy or has had systemic chemotherapy within the last 6 weeks
- History of gross hematuria requiring instrumentation or hospitalization within the last 12 months
- Cystoscopy contraindicated due to another condition or anatomy
- History of pelvic radiation
- History of schistosomiasis
- History of chronic (>3 months) indwelling Foley catheter or chronic (>3 months) bladder stones
- Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
- 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)
- Known current pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 88 years old?
Where in United States
- Albany MED Health SystemAlbany, United StatesContact: Adrien N Bernstein, MDTaking people
- Austin Urology InstituteAustin, United StatesContact: Amanda MasonNot yet recruiting
- UT Southwestern Medical CenterDallas, United StatesContact: Perla LopezTaking people
- Dayton Physicians NetworkDayton, United StatesContact: Sandy EversTaking people
- Advanced Urology Institute - Daytona BeachDaytona Beach, United StatesContact: Samuel Lawindy, MDTaking people
- Urology Associates of Central CaliforniaFresno, United StatesContact: Kristin SanteufemiaTaking people
- Chesapeake Urology Research AssociatesHanover, United StatesContact: Rian J Dickstein, MDTaking people
- Penn State Medical Center, Urology ResearchHershey, United StatesContact: Sneha PatelTaking people
- Urology Centers of AlabamaHomewood, United StatesContact: Meredith A Sharpton, PA-CTaking people
- Southern UrologyLafayette, United StatesContact: Donna SmithNo longer taking part
- Comprehensive UrologyLos Angeles, United StatesContact: Kiarash Michel, MDTaking people
- Urology Group of Southern CaliforniaLos Angeles, United StatesContact: Shahzada KhurramTaking people
- University of Wisconsin - MadisonMadison, United StatesContact: Rebecca MarrahTaking people
- Urologic Specialists of Northwest IndianaMerrillville, United StatesContact: Shawna ClemonsTaking people
- Urology Associates of MobileMobile, United StatesContact: Pamela R ManleyTaking people
- Vanderbilt University Medical CenterNashville, United StatesContact: Kristen R Scarpato, MDTaking people
- Urology Associates, P.C.Nashville, United StatesContact: Donna SmithNo longer taking part
- Integrated Medical ProfessionalsNew York, United StatesContact: Michael YangTaking people
- Premier Medical Group of the Hudson Valley, P. C.Poughkeepsie, United StatesContact: Lisa Cotton, RN, BSN, CCRCTaking people
- Summit HealthVoorhees Township, United StatesContact: Alice DrewTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Test ArmTreatment being tested
The site will receive the Cxbladder Triage+ result and the urologist study investigator discuss it with the patient before making a shared decision whether or not to proceed with cystoscopy.
Treatment: Cxbladder Triage Plus
- Control armNo study treatment, for comparison
Neither the site nor the patient will receive the Cxbladder Triage+ result. The decision whether or not to proceed with cystoscopy will be made following standard of care.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cystoscopic REDuction In BLadder Evaluations for Microhematuria - A Prospective Randomized, Controlled, Clinical Utility Study for Evaluation of Microhematuria (The CREDIBLE Study)
- Plain-language title
- Tests a urine check to help decide on bladder camera exams in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06394869, who can take part
- Record updated
- 2 July 2026