You have accessJournal of UrologySurgical Technology & Simulation: Instrumentation & Technology III1 Apr 2018PD40-08 A NOVEL URETHRAL CATHETER DESIGN TO BOTH PREVENT AND MINIMIZE MORBIDITY WITH INTRA-URETHRAL CATHETER INJURY (IUCI) Hanson Zhao, David Aaronson, and Maurice Garcia Hanson ZhaoHanson Zhao More articles by this author , David AaronsonDavid Aaronson More articles by this author , and Maurice GarciaMaurice Garcia More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.1933AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The incidence of iatrogenic urethral catheterization injuries (IUCI′s), wherein the retention balloon is inflated with the urethra, is ˜ 6.7 per 1000 catheterizations, and is ≥ the reported incidence of CAUTI. Urethral catheters are placed by physicians and nurses with varying degree of catheter-expertise, from all specialties. The morbidity and financial cost of IUCI′s to the U.S. healthcare is substantial. We developed a novel catheter design to help prevent IUCI′s. Here we describe how we validated the final design, and compared performance of working prototypes to a standard BARD catheter using bench-top studies and using fresh transected penis specimens. METHODS We describe our catheter design, which has a pilot-balloon (PB) along the inflation-port, which signals when the retention balloon is subject to high filling pressure. We manufactured 16 Fr. all-silicone Coude prototypes (otherwise identical to similar BARD catheters).Ideal PB wall-thickness was based on trials that resulted in PB inflation ONLY when the retention balloon (RB) was filled within a 30 Fr metal tube and NEVER when filled in an open environment. Next, we inflated the RB of six final prototypes and 6 BARD catheters with contrast (under Fluoro) with the RB inside the penile urethra of whole-penises resected during transgender vaginoplasty surgery. After balloon inflation to 10 ml, RB image pixel length, vertical width, and area were measured. RESULTS Ideal PB wall thickness was calculated from a ratio of PB/RB filling pressures. Unrestricted RB filling pressures ˜ identical among all catheters. Filling within a 30 Fr tube resulted in prototype RB pressures significantly lower than with the BARD catheter and did not vary significantly across samples. The RB of our 6 prototype and 6 BARD catheters was then filled (with contrast, under Fluoro) inside the penile urethra of discarded whole-penis specimens, we made observations #1-4 in Table I. CONCLUSIONS This work demonstrates the utility and feasibility of creating a pilot-balloon design for urethral catheters which off-loads retention-balloon volume to protect the urethra from injury. A similar design can be made for latex-catheters. Given the ubiquity of the catheter, and the high morbidity of IUCI′µs, further attention to design innovation for this device is warranted. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e807 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Hanson Zhao More articles by this author David Aaronson More articles by this author Maurice Garcia More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...