MP08-04: Use of Antibiotics in Patients Undergoing Follow-up for Non-muscle invasive bladder cancer with either Flexible cystoscopy or the Urinary Biomarker Test Xpert® Bladder Cancer Monitor: a secondary Outcome from a Randomised Clinical Trial
Introduction: Patients with non-muscle-invasive bladder cancer (NMIBC) have a high recurrence rate, which leads to frequent flexible cystoscopies (FC). Aside from the burden of undergoing FC, there is a risk of urinary tract infection (UTI) following FC. Follow-up of NMIBC with non-invasive urinary biomarker tests could reduce the number of FCs, and thus potentially the need for antibiotics due to UTI. Furthermore, because UTIs are among the most common infections, any reduction in incidence could reduce development of multiresistant uropathogenic bacteria. In this study, a secondary outcome from the DaBlaCa-15 trial is reported. The objective was to compare the number of patients with collected prescriptions for antibiotics for UTI in patients followed with FC versus patients followed primarily with the urinary biomarker test Xpert® Bladder Cancer Monitor (XBCM) (CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries. Not available in the United States.). Methods: A two-arm randomised non-inferiority trial enrolling 392 patients with previous high-grade NMIBC was conducted. In the intervention arm, patients were followed with XBCM every four months with only one yearly pre-scheduled FC. Patients in the control arm underwent FC every four months for two years. The number of patients who collected prescriptions for UTI during the study period was compared both peri- and post-FC and for visits where a FC was not pre-scheduled. Results: During follow-up, 23.7% of patients in the intervention arm collected a prescription compared to 31.0% in the control arm (RR 0.76; 95% CI 0.55-1.06; p = 0.11). When analysing visits without a pre-scheduled FC, 6.3% of patients in the intervention arm collected a prescription in the 14 days after a visit versus 13.4% in the control arm (RR 0.47; 95% CI 0.25-0.90; p = 0.02). Similarly , the peri-FC use of antibiotics was 7.9% in the intervention arm, compared to 15.0% in the control arm (RR 0.53; 95% CI 0.29-0.94; p = 0.03). A reduction in the number of FCs performed in the intervention arm was observed (39.1% versus 98.3%; p < 0.0001). Conclusions: The findings of the present study support the hypothesis that replacing cystoscopy with XBCM can reduce the use of antibiotics for UTI during follow-up of NMIBC. Thus, the morbidity of follow-up of NMIBC with FC can be reduced, resulting perhaps in less development of multiresistant uropathogenic bacteria and increased quality of life. SOURCE OF Funding: Supported by Cepheid Inc.