OBJECTIVES: The processing of standard flexible cystoscopes is time-consuming and potentially hazardous to healthcare staff. We evaluated a novel flexible cystoscope system containing a disposable sheath, which obviates the need for chemical processing. METHODS: A total of 100 patients undergoing office cystoscopy were randomized into a "sheath" or a control group (n = 50 for each group). Disposable Slide-On sheaths and the CST-2000 Flexible Cystoscope System were used in the former group. A standard 16F flexible cystoscope, manually cleaned and disinfected with Cidex OPA or Rapicide, was used in the control group and the preparation times were recorded. Questionnaires to assess cystoscope setup, handling, optical quality, and patient comfort were completed by the physician, nursing staff, and patients. RESULTS: Data were available for 97 patients. The mean total time required for preparation of the cystoscopes was 10.7, 14.7, and 42.2 minutes for the sheath (n = 49), Rapicide (n = 21), and Cidex OPA (n = 27), respectively (P <0.01 for all comparisons). The control group scored better than the sheath group with regard to ease of cystoscope insertion (9.1 versus 7.7), cystoscope handling (8.8 versus 8.1), and irrigation setup (8.8 versus 8.2; all P < or = 0.01). No statistically significant difference was found between groups for procedure time, optical quality, or patient comfort, either during or after the procedure. CONCLUSIONS: The EndoSheath System can save 4 to 31 minutes of processing time while avoiding exposure to irritants found in conventional soaking methods. Although maneuvering of the sheathed cystoscope was slightly more difficult, the optical quality and patient comfort were similar to those of standard flexible cystoscopy.
RCT Entities:
OBJECTIVES: The processing of standard flexible cystoscopes is time-consuming and potentially hazardous to healthcare staff. We evaluated a novel flexible cystoscope system containing a disposable sheath, which obviates the need for chemical processing. METHODS: A total of 100 patients undergoing office cystoscopy were randomized into a "sheath" or a control group (n = 50 for each group). Disposable Slide-On sheaths and the CST-2000 Flexible Cystoscope System were used in the former group. A standard 16F flexible cystoscope, manually cleaned and disinfected with Cidex OPA or Rapicide, was used in the control group and the preparation times were recorded. Questionnaires to assess cystoscope setup, handling, optical quality, and patient comfort were completed by the physician, nursing staff, and patients. RESULTS: Data were available for 97 patients. The mean total time required for preparation of the cystoscopes was 10.7, 14.7, and 42.2 minutes for the sheath (n = 49), Rapicide (n = 21), and Cidex OPA (n = 27), respectively (P <0.01 for all comparisons). The control group scored better than the sheath group with regard to ease of cystoscope insertion (9.1 versus 7.7), cystoscope handling (8.8 versus 8.1), and irrigation setup (8.8 versus 8.2; all P < or = 0.01). No statistically significant difference was found between groups for procedure time, optical quality, or patient comfort, either during or after the procedure. CONCLUSIONS: The EndoSheath System can save 4 to 31 minutes of processing time while avoiding exposure to irritants found in conventional soaking methods. Although maneuvering of the sheathed cystoscope was slightly more difficult, the optical quality and patient comfort were similar to those of standard flexible cystoscopy.