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

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 requiring FC who met inclusion criteria were randomly assigned to have their procedure performed...

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Veröffentlicht in:Journal of endourology 2023-01, Vol.37 (1), p.80-84
Hauptverfasser: Holmes, Angela, O'Kane, Dermot, Wombwell, Amy, Grills, Richard
Format: Artikel
Sprache:eng
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Zusammenfassung: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 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%. One hundred one patients completed the study (  = 50 trial,  = 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 (  = 0.415) or total theater use time (  = 0.441) between groups. Adverse event rates were 4.08% and 4.16% in the trial group and control groups, respectively. 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.
ISSN:0892-7790
1557-900X
DOI:10.1089/end.2022.0210