Société Internationale d’Urologie Journal

Haematuria continues to be one of the most frequent and resource-intensive referrals in urology [...]

Background: Haematuria is a common presenting symptom of Urothelial Carcinoma (UC). Traditionally, the “triple workup”—comprising flexible cystoscopy, voided urine cytology and upper tract imaging is used as the standard diagnostic approach for evaluating these patients. However, these investigations can be invasive, time-consuming, and costly. Cxbladder, a urine based genomic biomarker, utilises a non-invasive, singular urine sample to calculate probability of UC based on a patient’s risk factors and gene expression. The aim of Cxbladder is to establish patients with a high probability of no UC being present, which suggests that the traditional investigations are not required. This study evaluates the performance of Cxbladder Triage compared to the standard triple workup in patients presenting with haematuria, excluding a diagnosis of UC. Methods: A prospective, observational study was conducted at a single Australian tertiary hospital. A total of 258 patients, who presented with haematuria from 2020 to 2023, underwent both a Cxbladder Triage test and standard triple workup, comprising three urine cytology samples, imaging and a flexible cystoscopy. Some patients required either a bladder biopsy or tumour resection to further diagnose and treat a suspected UC. Diagnostic accuracy was assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and the proportion of missed tumours. Results: Overall, 5.4% of patients, presenting with haematuria were diagnosed with UC (n = 14). Cxbladder Triage demonstrated a sensitivity of 92.9% (95% confidence interval [CI]: 66.0–99.8) and an NPV of 92.9% (95% CI: 66.0–99.8). This was higher than cytology alone, which recorded a sensitivity of 42.9% (CI 9.9–81.6%) and NPV of 78.9% (95% CI: 54.4–94.0) for the detection of UC. When cytology and imaging were combined to investigate UC, the sensitivity and NPV recorded were 75.0% (95% CI: 42.8–94.5) and 80.0% (95% CI: 51.9–95.8), respectively. The proportion of UC cases missed by Cxbladder Triage was 6.7% (n = 1). Conclusions: In our cohort of patients presenting with haematuria, Cxbladder Triage offers a non-invasive alternative to the traditional workup for the detection of UC, with both a high sensitivity and NPV. Cxbladder Triage offers an alternative diagnostic workup for low-risk patients, which has the potential to reduce unnecessary invasive tests, procedures, and cost to the healthcare system.

Introduction: Low-risk non-muscle-invasive bladder cancer (NMIBC) is associated with extremely low rates of progression and cancer-specific mortality. Current surveillance strategies recommend yearly cystoscopic surveillance after the initial 12-month period. Cystoscopic surveillance is costly, leading bladder cancer to be one of the most economically burdensome diseases. We investigated the use of a negative urinary dipstick for haematuria (UDH) in predicting the absence of recurrence. Materials and Methods: All patients undergoing flexible cystoscopy at our institution underwent urinary dipstick testing immediately prior to their procedures. We conducted a retrospective analysis of all patients undergoing cystoscopic surveillance for known low-risk NMIBC at our institution between January 2018 and August 2024. All patients had low-risk NMIBC, as defined by American Urological Association (AUA) guidelines, at the time of flexible cystoscopy. Patient demographics, cystoscopy operation records, and subsequent biopsy results were reviewed. Results: A total of 124 patients who underwent 310 cystoscopies were included in the analysis. The overall rate of UDH positivity was 54%. The negative predictive value (NPV) and sensitivity of UDH for the absence of bladder cancer recurrence were 95.7% and 81.2%, respectively. All cases of bladder cancer recurrence with negative UDH were low-grade Ta (n = 5) or papillary urothelial neoplasm of low malignant potential (PUNLMP) (n = 1). There was no difference in the NPV and sensitivity within 12 months of diagnosis (NPV = 95.4%, sensitivity = 83.3%) and 12 months after diagnosis (NPV = 95.8%, sensitivity = 80%). Conclusions: UDH has a high NPV and sensitivity for recurrence in low-risk NMIBC. No cases of high-grade tumors or carcinoma in situ were undetected by UDH in this study. UDH shows promise as an inexpensive adjunct test that can reduce the high economic burden of surveillance of non-muscle-invasive bladder cancer.