Abstracts from the New England Section of the AUA 2021

NE-AUA 2021 Abstracts P20 Concurrent Poster Session II 45 Vibegron Shows Meaningful Changes in Clinical Endpoints in Patients with Overactive Bladder: Analyses from EMPOWUR Michael Kennelly, MD 1 , Cynthia J. Girman, DrPH, FISPE 2 , Jeffrey Frankel, MD 3 , David Staskin, MD 4 , Susann Varano, MD 5 , Matt T. Rosenberg, MD 6 , Diane K. Newman, DNP, ANP-BC 7 , Denise Shortino, MS 8 , Rachael A. Jankowich, RN, MSN 8 , Paul N. Mudd, Jr., PharmD, MBA 8 1 Carolinas Medical Center, Charlotte, NC, USA; 2 CERobs Consulting, LLC, Chapel Hill, NC, USA; 3 Seattle Urology Research Center, Seattle, WA, USA; 4 Tufts University School of Medicine, Boston, MA, USA; 5 Clinical Research Consulting, Milford, CT, USA; 6 Mid-Michigan Health Centers, Jackson, MI, USA; 7 Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 8 Urovant Sciences, Irvine, CA, USA Introduction: Reductions in bothersome symptoms of overactive bladder (OAB) are reported to demonstrate improvement in clinical trials, often without interpreting meaningfulness to patients. In the 12-week phase 3 EMPOWUR trial, vibegron significantly reduced micturitions, urgency episodes, and urge urinary incontinence (UUI) episodes vs placebo (P<0.01, each). These analyses used an anchor-based approach to interpret the meaningfulness of symptom reduction with the patient global impression of change (PGI-C). Materials & Methods: Median change from baseline (CFB) at week 12 in micturitions, urgency episodes, and UUI episodes was generated for each PGI-C category, pooled across treatments. Percentages of patients achieving these reductions in symptoms were determined. Results: Patients who experienced greater CFB at week 12 in each endpoint reported greater improvement in PGI-C. Median reductions from baseline in OAB endpoints pooled across treatment groups were higher than thresholds patients perceived as improved based on PGI-C: ≥15% reduction in micturitions (moderately better; Figure 1 ), ≥50% reduction in urgency episodes (much better; Figure 2 ), and ≥90% reduction in UUI episodes (much better; similar to ≥75% reduction seen in EMPOWUR [PGI-C: moderately better]; Figure 3 ). Significantly more patients receiving vibegron vs. placebo achieved these reductions (P<0.05, each). Conclusions: Significantly more patients treated with vibegron vs. placebo in EMPOWUR achievedmeaningful reductions inmicturitions and urgency/ UUI episodes that were associated with patient-perceived improvement.