Abstracts from the New England Section of the AUA 2020: A Virtual Experience

© The Canadian Journal of Urology TM : International Supplement, August 2020 68 Once-Daily Vibegron 75 mg for Overactive Bladder (OAB): Double-Blind 52-Week Results From an Extension Study of the International Phase 3 Trial (EMPOWUR) David Staskin, MD 1 , Jeffrey Frankel, MD 2 , Susann Varano, MD 3 , Denise Shortino, MS 4 , Rachael Jankowich, RN, MSN 4 , Paul N Mudd, Jr., PharmD, MBA 4 1 Tufts University School of Medicine, Boston, MA; 2 Seattle Urology Research Center, Seattle, WA; 3 Clinical Research Consulting, Milford, CT; 4 Urovant Sciences, Irvine, CA Introduction: Vibegron is a novel, oral, once-daily β3-adrenergic receptor agonist being investigated for overactive bladder (OAB) treatment. In the phase 3 randomized, double- blind, 12-week EMPOWUR trial (N = 1518), vibegron 75 mg statistically significantly improved primary OAB endpoints of daily micturitions and urge urinary incontinence (UUI) ( p < 0.001 each) and key secondary endpoints vs. placebo; tolterodine extended- release 4 mg was active control. Vibegron tolerability was favorable. Results from the 40-week EMPOWUR extension are reported. Materials & Methods: EMPOWUR enrolled adults aged ≥ 18 years with OAB wet (incontinence) or dry. The 40-week extension enrolled ~500 EMPOWUR completers. Those receiving vibegron or tolterodine in EMPOWUR continued; placebo patients received vibegron or tolterodine (1:1). The randomization was stratified by OAB type and sex. The primary endpoint was vibegron safety and tolerability. Key efficacy endpoints were changes from EMPOWUR baseline at week 52 in average daily micturitions, UUI, urgency, and total incontinence. Results: Among 505 randomized, treated extension patients (n = 273, vibegron; n = 232, tolterodine), median age was 64.0 years (mean age: 61.1 years); 46.5% were aged ≥ 65 years; 78.2%were women; and 78.2% had OABwet. Baseline characteristics and extension completion rates (vibegron, 85.8%; tolterodine, 84.1%) were similar.Adverse events (AEs) occurred in 62.6% of vibegron and 54.3% of tolterodine patients; 4 (1.5%) vibegron and 8 (3.4%) tolterodine patients discontinued study medication due to an AE. Key AEs (> 5% for vibegron) for vibegron and tolterodine, respectively, were hypertension (8.8% and 8.6%), urinary tract infection (6.6% and 7.3%), and headache (5.5% and 3.9%). One death (due to arteriosclerotic disease, judged not related to study drug by investigators or sponsor) occurred in the vibegron group. Among EMPOWUR vibegron and tolterodine patients receiving 52 weeks of active treatment, there was adjusted mean change from EMPOWUR baseline improvement at week 52 in all key OAB endpoints: micturitions (-2.4, vibegron [n = 152]; -2.0, tolterodine [n = 120]; Figure 1), UUI (-2.2, vibegron [n = 125]; -1.7, tolterodine [n = 91]; Figure 1), urgency (-3.4, vibegron [n = 152]; ‑3.2, tolterodine [n = 120]), and total incontinence (-2.5, vibegron [n = 125]; -1.9, tolterodine [n = 91]); 61.0% of 143 vibegron-treated patients had a ≥ 75% reduction in UUI, and 40.8% became dry (100% reduction) at week 52. Conclusions: Consistent with the placebo-controlled EMPOWUR phase 3 study, vibegron demonstrated a favorable long-term safety profile in extension patients with OAB and showed durable improvements in micturitions, UUI, urgency, and total incontinence; 40.8% of wet patients became dry at week 52. FigureLegend: Changefrombaseline leastsquaresmean;52-weekgroupsonly.Covariates included in the mixed model for repeated measures are study visit, treatment, treatment by study visit interaction, baseline, OAB type (micturitions only), and sex. Baseline value is computed using the run-in diary from the EMPOWUR 12-week study. LS = least square; UUI = urge urinary incontinence. 67 Anovaginal Distance and UTI Frequency inOlder Women: Does Distance Matter? Paula B. Bellin, MD , Brooke Moore, BS, Garen Kroshian, BS, Kirsten Lee, BS UMassMemorial Medical Center, Worcester, MA Introduction: Short urethral length and anovaginal distances are often cited as factors that increase a woman’s risk of developing UTIs. However, little data exists to support either of these conclusions. Given the high prevalence of UTIs along with the severity of the associated sequelae, particularly in older patients, it is important to understand the multifactorial etiology of this disease. To determine how perineal anatomy may impact the development of recurrent UTIs, we measured anovaginal distance in post- menopausal women. Materials & Methods: An IRB-approved, case-control study was performed in the department of Urology at an academic medical center. The selected patient population was women over 55 years of age. Patients were deemed ineligible for our study if they had any of the following: history of GU anatomic anomalies, > 1 kidney stone since menopause, history of gender affirmation surgery, current/recent urinary catheter use, history of colostomy, immunocompromised, active GU/gynecologic cancer, or current anticholinergic, SGLT-2 inhibitor, 1 st generation antihistamine, or antipsychotic use. Eligible patients were identified through a pre-visit EMR review and were sorted into two study groups based on the presence or absence of recurrent UTIs, as defined by ≥ 3 culture-positive UTIs over the course of one year. Patients were consented appropriately and asked to complete a questionnaire regarding potential confounders, such as alcohol use and sexual activity. Anovaginal distance was measured from the posterior vaginal introitus to the anterior aspect of the anus. Measurements were taken using a Pop-Q exam stick (Marina Medical Instruments) that contained millimeter markings. Data was stored in the REDCap secure online system and analyzed using Microsoft Excel 2019. Results: To date, the results from thirty-three patients have been evaluated. The mean anovaginal distance was 33.3 mm (SD: 8.3) for cases and 39.5 mm (SD: 6.3) for controls (p = 0.02). With the exception of sexual activity, which was significantly greater in the control group (p = 0.03), there was no difference in potential confounders across the two groups, including diabetes and BMI (Table 1). Conclusions: Variations in perineal anatomy may contribute to the development of UTIs. This initial study demonstrates that women with recurrent UTIs have significantly shorter anovaginal distances than women without recurrent UTIs. These findings should be emphasized during clinical encounters, as behavioral modifications, such as front-to- backwiping and post-coital voiding, may be preventative for at-risk patients. Interestingly, sexual activity was also significantly greater in the control group, suggesting a secondary finding of unclear etiology.Although it is unlikely that sexual activity is protective, further research is needed to better understand the value of this outcome.As more data is collected, we hope to gain greater insight into how anatomy and sexual activity impact UTI risk. Scientific Session VII: Female/Neuro 30