Prospective Analysis of Versatility and User Satisfaction with a Novel Single-Use Cystoscope with Working Channel

Abstract

Introduction: In the present study, a prospective systematic assessment of the clinical utility of the Ambu® aScopeTM 4 Cysto Reverse Deflection with regard to image quality, maneuverability, and navigation in an outpatient and inpatient setting was performed.

Materials and methods: A prospective multicenter study was performed for evaluation of the instrument during routine cystoscopy. We evaluated the clinical performance of the instruments using a standardized user questionnaire in different categories including image quality, treatment success, imaging of all areas of the urinary bladder, quality of navigation, flexibility of the endoscope, and satisfaction with the device. Statistical analyses were performed by SPSS using the Kruskal-Wallis and Wilcoxon-Mann-Whitney tests. A p value of p ≤ 0.05 was defined as statistically significant.

Results: A total of 200 cystoscopies were performed, and the questionnaire response rate was 100%. The image quality was rated as very good in 65.5% (n = 131), good in 30.5% (n = 61), and neutral in 4% (n = 8) of cases. The criteria for poor or very poor were not mentioned. The characteristic "treatment success based on image quality" was also evaluated as very good in 49% (n = 98) and good in 50.5% (n = 101). The analysis revealed a very good or good overall impression of the examiners in all cases. Replacement of the cystoscope was not necessary during any of the examinations. However, in 3 cases, technical difficulties were documented. Further analysis of the data showed that physicians with less professional experience rated the visualization of the urinary bladder (p = 0.007) and the treatment success with regard to image quality significantly worse (p = 0.007).

Conclusion: The Ambu® aScope™ 4 Cysto Reverse Deflection shows high satisfaction values among users in clinical routine. In analogy to other studies with flexible endoscopes, urologists with more professional experience show higher satisfaction values than examiners with less training in flexible endoscopy.

Keywords: Cystoscopy; Endoscopic treatment; Novel single-use cystoscope.