This article describes a randomized controlled trial by Krebs et al in which 100 patients were assigned to undergo flexible cystoscopy using either an unsheathed cystoscope (Karl Storz Endoscopy, Culver City, CA) that had been disinfected with high-level reprocessing employing ortho-phthalaldehyde or glutaraldehyde or a cystoscope covered with the EndoSheath® Technology containing irrigation and working channels (CST-2000 Flexible Cystoscope with Slide-On® EndoSheath® System, Vision Sciences, Natick, MA). Three patients were subsequently excluded from the study after a review of consent forms; therefore, the final analysis included data from 49 patients in the disposable sheath group and 48 in the control group.
Cystoscope preparation times in the EndoSheath® Technology and unsheathed groups were recorded. The physicians assigned scores on a 10-point scale (with 1 being the worst and 10 the best possible score) for ease of cystoscope insertion, optical quality, cystoscope handling, irrigation setup/handling, ease of instrument passage, and patient comfort. The patients used the same scale to rate their comfort during the cystoscopy procedure, comfort during postcystoscopy voiding, and overall satisfaction with the procedure. The researchers conducted a cost-analysis comparison of sheathed and unsheathed cystoscopy that considered the following expenses: initial purchase price of the cystoscope, cystoscopy repair/ replacement cost, cost of disposables (EndoSheath® Technology versus disinfecting agents), and hours of work by the nursing staff .
The study found that the mean total times required to prepare the cystoscope for use were 11, 15, and 42 minutes, respectively, in the EndoSheath® Technology group, glutaraldehyde group, and orthophalaldehyde group (P < 0.01 for the EndoSheath® Technology group compared with each of the other two groups). This represented a 27% reduction in preparation time with the use of disposable sheaths. Optical quality, ease of instrument passage through the working channel, and patient comfort assessed by the physician were equivalent in the disposable sheath and unsheathed group; cystoscope insertion and handling and irrigation setup/handling were significantly easier in the unsheathed group. There were no differences between the two groups in patients’ assessments of comfort. The cost analysis found that using sheathed cystoscopes was less expensive than using unsheathed cystoscopes and orthophthalaldehyde disinfection.
Krebs et al commented that even though the urologists in the study found the sheathed cystoscope slightly more difficult to operate than the standard instrument, the fact that optical quality with the two endoscopes was determined to be equivalent suggests that diagnostic accuracy would not be affected by use of the EndoSheath® Technology. The researchers concluded that the increase in productivity associated with EndoSheath® Technology could provide a cost advantage over standard cystoscopy by obviating the need for backup cystoscopes in busy urologic practices.