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ABSTRACT
AIM: To examine prospectively the impact of adding a urinary biomarker of bladder cancer (Cxbladder Triage™, CxbT) to a clinical pathway for investigating haematuria.
METHODS: The clinical outcome of 571 patients with haematuria who presented to their general practitioner was reviewed. Outcome measurements included the findings of laboratory tests, imaging, cystoscopies, histology and specialist assessments. The data were used to model a theoretical clinical pathway that involved initial screening using CxbT in combination with imaging, and only test positive patients being referred for specialist assessment and cystoscopy.
RESULTS: All patients underwent cystoscopy and 44 transitional cell carcinomas were diagnosed in the study cohort, with two low-risk cancers missed by CxbT, one of which was also not detected by imaging. When combined, imaging and CxbT had a sensitivity of 97.7% and negative predictive value of 99.8%.
CONCLUSIONS: In our series, all significant bladder cancers were diagnosed by imaging and CxbT before cystoscopy was undertaken. The high negative predictive value of this clinical pathway would allow approximately one-third of patients with haematuria to be managed without cystoscopy.
The causes of asymptomatic haematuria are numerous. As such the investigating algorithm for haematuria is composed of a number of tests. Approximately 600 patients are accepted each year to the Canterbury District Health Board (DHB) Urology Department for evaluation of haematuria. All referrals are accepted if they have laboratory confirmation of haematuria and the investigations completed.
One of the most common important causes of haematuria is bladder cancer. While a number of these are detected on imaging, the 'gold standard' for diagnosing bladder cancer is cystoscopy.1 While generally well-tolerated by patients, flexible cystoscopy is uncomfortable and may have adverse post-procedural consequences.2'3 Anecdotally, it is the test in the haematuria algorithm least cherished by patients and also necessitates patients seeing a specialist urologist. If it were safe not to undertake cystoscopy in a group of patients presenting with haematuria, then their work-up could potentially be completed by clinicians other than a urologist, such as a general practitioner (GP).
The need to improve risk stratification of patients who may require cystoscopy and imaging was emphasised in a recent review of guidelines for assessing microhaematuria.4 Numerous biomarkers have been identified in urine or blood samples that have the potential to detect...