Comparison of Hexaminolevulinate Based Flexible and Rigid Fluorescence Cystoscopy with Rigid White Light Cystoscopy in Bladder Cancer: Results of a Prospective Phase II Study

Abstract

Introduction and Objective: Several studies have shown that rigid fluorescence cystoscopy (RFC) with hexaminolevulinate (HAL) is superior to standard rigid white light (RWLC) cystoscopy in diagnosing bladder tumours, with a clinically relevant impact on the patient's management. These studies, however, have been done with rigid cystoscopes. We carried out a study to evaluate whether the technique of fluorescence cystoscopy with HAL was also feasible with a specially designed flexible fluorescence cystoscope (FFC). Methods: 20 patients with known or suspected bladder cancer were included in a comparative within patient controlled Phase II study. All patients signed informed consent. All patients received 50 ml of HAL (Hexvix ®) 8 mM 1 h prior to transurethral resection. Using a D-light-C ® system (Storz, Germany), FFC and RFC were performed followed by RWLC. All lesions visible during these three cystoscopies were mapped, taped and resected. Results: In these 20 patients (mean age 71 years (49–89), 3 females) mean HAL instillation time was 81 min. Overall 27 histologically confirmed lesions were found in 19 patients. Detection rates in these 19 patients were 14 with FFC, 17 with RFC and 15 with RWLC. Of the 27 lesions 19 were detected with FFC, 23 with RFC and 20 with RWLC. Overall fluorescence intensity using the flexible system was 76% (30–147%) as compared to RFC using a visual analogue score. No side effects were noted which were attributable to HAL. Conclusion: The use of FFC is feasible and seems to be comparable to RWLC and slightly inferior to RFC. Larger studies should determine the role of flexible fluorescence cystoscopy.