Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria - Trial NCT05889195

Timeline & Enrollment

Primary Outcome

The alignment of Cxbladder Detect-plus results with the standard of care diagnostic result for the presence or absence of UC, to validate Cxbladder Detect-plus performance in subjects with microscopic hematuria.

Summary

It is of current debate whether the use of invasive (referring to a process that requires
 insertion into the body) standard of care procedures such as a cystoscopy which is a
 procedure to look inside the bladder using a thin camera called a cystoscope, is appropriate
 for use in patients with microscopic hematuria or blood in urine invisible to the naked eye.
 This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low
 in this population group, approximately 3%. Invasive procedures such as a cystoscopy comes
 with anxiety and pain, in addition to other potential side effects. This has resulted in low
 admittance in urology clinics for cystoscopy with hematuria (blood in urine) patients.
 Therefore, there is a need for a more simple, non-invasive test that can accurately detect
 the presence or absence of disease (urothelial carcinoma) in patients with microscopic
 hematuria. There is a potential role Cxbladder, a non-invasive, urine based test, can fill
 this role.

ICD-10 Classifications