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.
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.
Prior history of bladder malignancy.
Prior history of upper tract UC or prostatic urethral UC.
History of gross hematuria requiring instrumentation or hospitalization within the last 12 months
Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch)
Parallel
Cxbladder Triage Plus
Diagnostic testCxbladder 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.
Cystoscopy rate
Difference in the proportion of cystoscopies performed in each arm.
Detection of urothelial carcinoma (UC)
Difference in the proportion of UCs found in each arm.
Cxbladder Triage Plus performance and test negative rate.
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.
Persistent hematuria.
Rate of persistent hematuria in patients choosing surveillance.
Missed UCs
Number of UCs in both arms identified during the surveillance phase.
Physician rationale
Physician-reported reasons for not following the study recommended pathway based on the Detect+ result.
Imaging Utilisation
Change in number and modality of imaging procedures
Dipstick Subgroup
Proportion of subjects enrolled via dipstick-positive hematuria who meet guideline-defined microhematuria based on urine microscopy.
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