Adult Urology Evaluation of Practice Efficiency with a Novel Sheathed Flexible Cystoscope: A Randomized Controlled Trial Alfred Krebs, James F. Borin, Isaac Y. Kim, Donna J. Jackson, Elspeth M. McDougall, and Ralph V. Clayman 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 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. UROLOGY 70: 883– 887, 2007. © 2007 Elsevier Inc. T he role of flexible cystoscopy in the office setting as a standard procedure for the diagnosis and treatment of lower urinary tract conditions has been well established for at least 20 years. 1,2 Currently available flexible cystoscopes all require cleaning and sterilization or high-level disinfection after each proce- dure. This process is time consuming and potentially hazardous to patients and healthcare staff because of the substances used for disinfection. In a busy practice with several urologists working si- multaneously, multiple cystoscopic procedures might need to be scheduled at the same time or at short inter- vals during the same day. Thus, the availability of more than one flexible cystoscope would be necessary. Addi- tionally, increasing pressure is being exerted on the healthcare delivery team to reduce costs while providing high-quality care and to increase the safety of the work environment. The efficiency of cystoscope reprocessing thus needs to be maximized, without compromising the adequacy of disinfection, diagnostic accuracy, or patient comfort. In the present study, we evaluated practice efficiency with a novel flexible cystoscope system containing a sterile disposable sheath that obviates the need for chem- ical processing. We also evaluated patient comfort, opti- cal quality, and maneuverability of the sheathed cysto- scope by the physician, as well as overall cost, compared with the standard flexible cystoscope. MATERIAL AND METHODS The clinical research protocol was approved by the institutional review board of our institution. From January 2005 to April 2006, 100 patients were randomized to undergo office cystos- R. V. Clayman receives royalties from Orthopedics Systems Incorporated, Greenwald Incorporated, Boston Scientific, and Cook Urological; holds stock in Applied Urology; receives laboratory support from Endocare, Boston Scientific, Cook Urological, Vision- Sciences, and Vascular Technologies Incorporated; and is a consultant for Karl Storz Incorporated. From the Department of Urology, University of California, Irvine, Medical Center, Orange, California Reprint requests: Alfred Krebs, M.D., Department of Urology, University of Cal- ifornia, Irvine, Medical Center, 101 The City Drive, Building 55, Room 304, Route 81, Orange, CA 92868. E-mail address: alfkrebs@yahoo.com Submitted: November 20, 2006; accepted (with revisions): June 29, 2007 © 2007 Elsevier Inc. 0090-4295/07/$32.00 883 All Rights Reserved doi:10.1016/j.urology.2007.06.1112