Clinical Utility of a Single-Use Flexible Cystoscope Compared with a Standard Reusable Device: A Randomized Noninferiority Study

Objective: A noninferiority assessment of single-use digital flexible cystoscopy (FC) compared with standard reusable FC for bladder cancer surveillance, and investigation of lower urinary tract symptoms. Patients and Methods: Patients requiring FC who met inclusion criteria were randomly assigned to have their procedure performed using a single-use cystoscope (Ambu^® aScope™ 4 Cysto System) or a standard reusable cystoscope (Olympus CYF-VH flexible video cystoscope). Primary outcomes were noninferiority of the single-use cystoscope, in terms of effective procedure completion rate, image quality, light quality, and maneuverability. Secondary objectives compared safety, operative, and perioperative time. The noninferiority margin was set at -10%. Results: One hundred one patients completed the study (n = 50 trial, n = 51 control). All primary outcomes demonstrated noninferiority of the single-use cystoscope, compared with standard reusable FC. Effective completion rate, image quality, light quality, and maneuverability between single-use and reusable cystoscopes were 100% and 98% (confidence interval [CI]: -0.059 to 0.019); 96% and 100% (CI: -0.014 to 0.092); 98% and 100% (CI: -0.018 to 0.058); and 98% and 100% (CI: -0.018 to 0.058). There was no difference in operation time (p = 0.415) or total theater use time (p = 0.441) between groups. Adverse event rates were 4.08% and 4.16% in the trial group and control groups, respectively. Conclusion: The single-use Ambu flexible cystoscope is noninferior to standard FC in terms of procedure completion and light quality, image quality, and maneuverability. Single-use flexible cystoscopes are an effective and safe alternative to reusable flexible cystoscopes and may act as a suitable alternative or adjunct in the urologist's armamentarium.