MP24-16 PLASMA AND URINARY PHARMACOKINETICS OF A NOVEL, ORAL SHIP1 ACTIVATOR AQX-1125 IN FEMALE PATIENTS WITH INTERSTITIAL CYSTITIS J. Curtis Nickel*, Kingston, Canada; Robert Evans, Winston Salem, NC; Patrick Tam, Judy Toews, Lloyd Mackenzie, Heidi Biagi, Stephen Shrewsbury, Vancouver, Canada INTRODUCTION AND OBJECTIVES: AQX-1125 is a novel SH2-containing inositol-5 0 -phosphatase 1 (SHIP1) activator previously demonstrated to modulate inflammation. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic condition of unknown etiology, associated with inflammation of the bladder epithelium. The LEADER- SHIP trial was a multicenter, randomized, double-blind, placebo- controlled, Phase 2 clinical trial investigating the ability of 200 mg AQX- 1125 to reduce pain in female patients with IC/BPS in North America. Here we assess the extent of bladder exposure to AQX-1125 over 6 weeks with trough drug levels in plasma and urine. METHODS: Blood and urine was collected after 28 and 42 days. Samples were analyzed for concentrations of AQX-1125 via HPLC-MS/MS methods and trough levels calculated. RESULTS: PK samples where collected from 35 patients ran- domized to AQX-1125. The mean/geometric mean plasma concentra- tions were 252/211 and 225/162 ng/mL for Days 28 and 42, respectively. The mean/geometric mean urine concentrations were 49,863/34,450 and 33,396/22,934 ng/mL for Days 28 and 42, respec- tively, at least 140-fold higher than the corresponding plasma levels. The trough plasma concentrations are similar to, or exceed, those anticipated for efficacy from earlier clinical trials and pre-clinical studies. CONCLUSIONS: The novel SHIP1 activator, AQX-1125 rea- ches the bladder of IC/BPS patients via both the bloodstream and the urine. The urinary route of elimination of AQX-1125 as parent com- pound may be an attractive property of the drug for IC/BPS. If once daily oral AQX-1125 proves effective in ameliorating symptoms of IC/BPS, both systemic and direct exposure of drug to the bladder may contribute to that response. This pharmacokinetic data supports continued development of AQX-1125 as an oral, once-daily therapy for IC/BPS. Source of Funding: Aquinox Pharmaceuticals MP24-17 PERVASIVE BIOFILM COVERAGE: AN ANALYSIS OF BIOFILM FORMATION IN INDWELLING URINARY CATHETERS Mohamed Ibrahim, Vrad Levering*, Eileen Lanham, James Parra, Harold Leraas, Gabriel Lopez, Bruce Klitzman, Andrew Peterson, Howard Levinson, Durham, NC INTRODUCTION AND OBJECTIVES: Over 30 million Foley catheters are used annually in the US. 20% of patients admitted to hospitals receive catheters and 400,000 patients develop hospital ac- quired urinary tract infections (CAUTIs) yearly. CAUTIs are preceded by asymptomatic biofilm formed within catheter lumen. Bacteria-excreted biofilm enables infection, and allows for development of antibiotic resistance. Furthermore, biofilms can grow in size to occlude catheter lumen, causing ascending pyelonephritis, and septicemia. Lack of knowledge about biofilm progression hampers developing anti-biofilm interventions. We quantified formation and progression of biofilm in urinary catheters of different duration dwell times. METHODS: Seventy-four catheters of different duration dwell times were collected from patients under an IRB-exemption approved by Duke University Medical Center. The catheters were analyzed for biofilm formation. 5cm portion of the middle of catheter was longitudi- nally split into equal halves, internal lumens were stained with crystal violet and percent area coverage was quantified. 3mm thick cross sections were cut from the middle portion of and imaged with 1:1 magnification, then average thickness of biofilm was measured in 4 regions in each section. External biofilm around catheter was stained with crystal violet and percent area coverage was quantified. Quantifi- cations done with ImageJ software. RESULTS: Analysis shows biofilm formed as early as 13 hours after catheter placement with 13.8% catheter coverage. D1-5 showed 50% biofilm coverage (n¼15, SEM+/-7.5) which increased to 93% by D28 onwards (n¼20, SEM+/-3.02). Biofilm thickness analysis demon- strated 43um thick biofilm by D1-5 (n¼15, SEM+/-5.4), 77um by D14, up to 138um by D28 onwards (n¼15, SEM+/-40). Analysis of external Foley wall revealed 13% biofilm coverage by D1-5 (n¼10, SEM+/-5.5) and 32% by D28 onwards (n¼14, SEM+/-13.1). Biofilm on the outside of catheter was less than internal biofilm (p<0.05). CONCLUSIONS: This is the first human study documenting natural history of biofilm in clinical practice. Biofilm formation starts immediately after catheter implantation, 50% coverage with biofilm as early as D1 reaching 93% by d28. Majority of biofilm is found within catheter suggesting a relationship between CAUTI and biofilm location. Future studies will aim at developing ther- apy to disrupt luminal biofilm, gaining clearer understanding of patient factors associated with biofilm formation. Source of Funding: Duke-Coulter Translational Partnership Grant MP24-18 FEASIBILITY OF NON-USE OF ANTIMICROBIAL PROPHYLAXIS IN MINIMALLY INVASIVE CLEAN SURGERY FOR RENAL OR ADRENAL TUMORS: A PROSPECTIVE STUDY OF 668 CASES Motohiro Fujiwara*, Masaharu Inoue, Minato Yokoyama, Toshiki Kijima, Takayuki Nakayama, Masaya Ito, Soichiro Yoshida, Junichiro Ishioka, Yoh Matsuoka, Noboru Numao, Kazutaka Saito, Yasuhisa Fujii, Kazunori Kihara, Tokyo, Japan INTRODUCTION AND OBJECTIVES: The routine use of anti- microbial prophylaxis (AMP) has potential to induce adverse effects and increase the rate of drug-resistant infection and the administration costs. According to some guidelines, no standard AMP is recom- mended in clean operations such as adrenalectomy (ADx), radical ne- phrectomy (RNx) or partial nephrectomy (PNx) in which the urinary tract is not opened. There is little evidence supporting this recommendation, however. We have preliminarily reported that AMP is not necessary in clean operations (Kijima et al. Urology 2012). In this study, we further evaluated the feasibility of non-use of AMP in an expanded cohort of patients who underwent minimally invasive clean surgery for renal or adrenal tumors. METHODS: Between October 2006 and June 2015, 947 consecutive patients underwent minimally invasive surgery for renal or adrenal tumors using gasless laparoendoscopic single-port surgery (GasLESS) techniques (Kihara et al. Int J Urol 2009; Springer 2015). Some patients were given AMP and were therefore excluded from the analysis; these included 46 patients with poorly controlled diabetes mellitus (hemoglobin A1c levels > 7.0 %), 107 with opening of the urinary tract during PN, 43 with ureteral stent placement prior to PNx and 83 with infections or other high-risk concomitant conditions. The remaining 668 patients who underwent ADx (n ¼ 154), RNx (n ¼ 287) or PNx (n ¼ 227) without AMP were included in this study. The primary outcome is the incidence of perioperative infection, which was cate- gorized into superficial surgical site infection (SSI) and deep SSI. RESULTS: Infectious complications occurred in seven cases (1.0%), including five superficial SSIs (0.7%) and two deep SSIs (0.3%). All infectious complications were successfully treated with antibiotics (Clavien-Dindo grade2). The total amount of antibiotics administered among the 668 patients in this surgical series was 81g. There were no significant differences between patients with and without infectious complications in clinical variables. CONCLUSIONS: AMP is avoidable in minimally invasive clean surgery for renal or adrenal tumors. On-demand use of antibiotics upon diagnosis of infection appears to be sufficient for the treatment of in- fectious complications. e276 THE JOURNAL OF UROLOGY â Vol. 195, No. 4S, Supplement, Saturday, May 7, 2016