Abstracts from the New England Section of the AUA 2021

NE-AUA 2021 Abstracts Scientific Session VI: General Urology, Clinical Practice and Academics Effects of Vibegron on Ambulatory Blood Pressure in Patients With Overactive Bladder: Results From a Double-Blind Study Jennifer King, PharmD 1 , MichaelA. Weber, MD 2 , WilliamB. White, MD 3 ,Ann Walker, MS 4 , Paul N. Mudd, Jr., PharmD, MBA 1 , Cornelia Haag-Molkenteller, MD, PhD 1 1 Urovant Sciences, Irvine, CA, USA; 2 State University of NewYork Downstate College ofMedicine, Brooklyn, NY, USA; 3 CalhounCardiologyCenter, University of Connecticut School of Medicine, Farmington, CT, USA; 4 Apex Biostatistics, Inc, Apex, NC, USA Introduction : Ambulatory blood pressure monitoring (ABPM) is a sensitive method used to determine whether small changes in blood pressure (BP) and heart rate (HR) are induced by new drugs. This randomized, double-blind, placebo-controlledABPM trial was used to characterize the BP andHR profile of the novel β 3 -adrenergic receptor agonist vibegron in patients with OAB. Materials& Methods : Patientswere randomized to once-daily vibegron 75mg or placebo for 28 days. The primary endpoint was change from baseline (CFB) to day 28 in mean daytime (waking hours) ambulatory systolic BP (SBP). Key secondary endpointswere CFB to day 28 inmean daytime ambulatory diastolic BP (DBP) and HR and in mean 24-hour ambulatory SBP, DBP, and HR. Point estimates for treatment groupmeans and treatment differences were presented with a 2-sided 90%confidence interval (CI). For the primary endpoint, the upper limit of the CI was evaluated against a criterion of 3.5 mmHg. Results : A total of 214 patients with OAB were randomized; of these, 96 in the vibegron group and 101 in the placebo group had evaluable ABPM measurements at baseline and day 28. Mean agewas 59.3 years and 74.6%were female; 39.6%and 30.7%of patients receiving vibegron or placebo, respectively, had pre-existing hypertension. The least squares mean difference (LSMD; 90% CI) CFB to day 28 in daytime SBP was 0.81 (-0.88, 2.49) mmHg for vibegron vs placebo ( Table ). Changes indaytimeDBPandHRwere comparable for vibegron and placebo ( Table ). The 90%CIs include 0, implying no statistically significant differences were seen in mean 24-hour SBP ( Figure ), DBP, or HR ( Table ). The most commonly reported treatment-emergent adverse event was hypertension (vibegron: n=5 [4.7%, 95% CI=1.6%-10.7%]; placebo: n=4 [3.7%, 95% CI=1.0%- 9.2%]); no event of hypertensionwithvibegronwas considered treatment related. Conclusions : In patients with OAB, once-daily vibegron was not associated with clinically meaningful or statistically significant effects on BP or HR and had a safety profile comparable with placebo. 66 COVID-19 Pandemic Results in Decreased Non-Urgent Urologic-Related Presentations to the Emergency Department Frances H. Kazal, BA 1 , Alejandra Balen, MD 2 , Janine Molino, PhD 2 , Christopher Tucci, RN 2 , Gyan Pareek, MD 2 , David Sobel, MD 2 1 The Warren Alpert Medical School at Brown University, Providence, RI, USA; 2 Minimally Invasive Urology Institute, The Miriam Hospital, Providence, RI, USA Introduction: Recent international medical research has focused specifically on changes to urologic presentations to the ED during the COVID-19 pandemic. Urologic-related visits to the ED are variable in their acuity, ranging fromnon-emergent to life-threatening. Our research focuses on differences in frequency between urgent and non-urgent visits during the first months of the pandemic to further elucidate delayed access to urologic care in the ED. We hypothesized that there would be a significant difference in urological cases evaluated in the ED during the first four months of 2019 compared to that of 2020. Furthermore, we investigated compelling trends amongst specific disease presentations during this time. Materials & Methods: Data was collected from emergency department records from two academic institutions in the United States.All adult urologic- related cases that presented to the ED, during the time periods of January- April 2019 and January-April 2020. Presentations were included if the chief complaint or diagnosis included urologic conditions. Retrospective data was collected on these individuals and through these two separate time intervals, 1,838 urological presentations were organized by diagnosis category. They were then divided into urgent and non-urgent categories based on clinical diagnosis. A retrospective analysis was performed comparing the frequency and type of urologic-related presentations. Interrupted time series regression models were used to determine how urologic-related ED visits changed due to the COVID-19 pandemic. All statistical analysis was performed using SAS version 9.4 (SAS Institute Inc., Cary, NC). Results: A total of 1,838 urologic-related ED visits were included in the analysis. ( Table 1 ). There was a statistically significant decrease in total urologic-related ED visits after the COVID-19 pandemic began by 76 visits per month with a 36.9% reduction (p=0.002). While there was no difference in the number of urgent ED visits due to the COVID-19 pandemic (p=0.13), there was a statistically significant decrease in non-urgent EDvisits by 68 visits per month with a 37% reduction (p=0.002). When examining the individual visit types, there were no differences in visit volume except for hematuria and nephrolithiasis/ureterolithiasis visits. There was a statistically significant decrease in hematuria-related ED visits, by 11 visits per month (p=0.03). Similarly, there was a statistically significant decrease in nephrolithiasis/ ureterolithiasis-related ED visits, by 28 visits per month (p=0.04). Conclusions: The COVID-19 pandemic coincidedwith a significant decrease in the number of non-urgent urologic presentations to our institution’s ED. Specifically, there was a significant decrease in the number of patients presenting with hematuria and nephrolithiasis-related issues. There was no significant decrease in the number of urgent urologic consults. Follow up study is indicated to investigate the downstream effects of delayed evaluation for these non-urgent urologic diagnoses. 65 33