PD37-10 AURICLOSENE IRRIGATION SOLUTION REDUCES INDWELLING URINARY CATHETER ENCRUSTATION AND PREVENTS BLOCKAGE: RESULTS OF A PHASE 2 CLINICAL STUDY

Abstract

You have accessJournal of UrologyStone Disease: New Technology II1 Apr 2014PD37-10 AURICLOSENE IRRIGATION SOLUTION REDUCES INDWELLING URINARY CATHETER ENCRUSTATION AND PREVENTS BLOCKAGE: RESULTS OF A PHASE 2 CLINICAL STUDY Todd Linsenmeyer, Lance Goetz, Michael Kennelly, Ramin (Ron) Najafi, William Costerton, David Stickler, Bernard Churchill, Keith Bley, Suriani Abdul Rani, Kenneth Krantz, and Susan Iovino Todd LinsenmeyerTodd Linsenmeyer More articles by this author , Lance GoetzLance Goetz More articles by this author , Michael KennellyMichael Kennelly More articles by this author , Ramin (Ron) NajafiRamin (Ron) Najafi More articles by this author , William CostertonWilliam Costerton More articles by this author , David SticklerDavid Stickler More articles by this author , Bernard ChurchillBernard Churchill More articles by this author , Keith BleyKeith Bley More articles by this author , Suriani Abdul RaniSuriani Abdul Rani More articles by this author , Kenneth KrantzKenneth Krantz More articles by this author , and Susan IovinoSusan Iovino More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2028AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Long-term indwelling urinary catheters are susceptible to blockage due to crystalline biofilms produced by urease-expressing bacteria. No controlled clinical data suggest that any existing catheter irrigation solution reduces the rate of catheter encrustation or blockage. To mitigate blockage, patients often accelerate the frequency of catheter exchanges and use systemic antibiotics. Auriclosene Irrigation Solution, 0.2% (AIS) was compared to saline in a prospective, double-blind, cross-over, multi-center, clinical study (CL1001) with respect to prevention of catheter encrustation and blockage. Auriclosene is N,N-dichloro-2,2-dimethyltaurine, a rapidly acting antimicrobial unlikely to promote bacterial resistance. METHODS Adult neurogenic bladder patients with long-term indwelling transurethral or suprapubic urinary catheters were enrolled. In Part 1, 0.2% auriclosene in preliminary formulation was dosed for 7 treatments over 2 weeks (3 times/week). In Part 2, AIS was dosed on the same schedule. In Part 3, AIS was dosed 2 times/week for 4 weeks (8 treatments). The control for all parts was 0.9% w/v saline. Subjects were randomized to one irrigation solution for the first treatment regimen, and after a washout period, irrigated with the other solution. A single treatment consisted of 2 sequential irrigations of 25 mL retained in the catheter for 15 minutes. Key inclusion criteria were a history of ≥ 2 episodes of catheter blockage and/or encrustation, and a urine pH ≥ 6.5. The primary efficacy outcomes were area of catheter luminal encrustation (as documented by computerized microscopic assessment), and catheter blockage based on subject/Investigator clinical observations. RESULTS The number of per-protocol subjects in Part 1, 2 and 3 were 14, 20 and 14, respectively. Analysis of catheter luminal encrustation in Part 3 revealed that catheters irrigated with AIS were on average 55% less encrusted than those receiving saline treatments. In per-subject comparisons, the reduction of encrustation with AIS was highly significant (P < 0.001). Nine of the 14 saline catheters became 100% encrusted, as opposed to none of the AIS catheters. Parallel effects were observed on clinical blockage. AIS was well tolerated. Additional clinical evaluation is underway to confirm the promising beneficial effects of AIS on catheter patency. CONCLUSIONS Twice weekly catheter irrigation with AIS significantly reduced encrustation and clinical blockage relative to saline. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e949 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Todd Linsenmeyer More articles by this author Lance Goetz More articles by this author Michael Kennelly More articles by this author Ramin (Ron) Najafi More articles by this author William Costerton More articles by this author David Stickler More articles by this author Bernard Churchill More articles by this author Keith Bley More articles by this author Suriani Abdul Rani More articles by this author Kenneth Krantz More articles by this author Susan Iovino More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...