#22974

Vibegron Shows Meaningful Changes in Clinical Endpoints in Patients with Overactive Bladder: Analyses From EMPOWUR
Frankel J1, Staskin D2, Varano S3, Kennelly M4, Newman D5, Rosenberg M6, Girman C7, Shortino D8, Jankowich R8, Mudd, Jr. P8
1. Seattle Urology Research Center, 2. Tufts University School of Medicine, 3. Clinical Research Consulting, 4. Carolinas Medical Center, 5. Perelman School of Medicine, University of Pennsylvania, 6. Mid-Michigan Health Centers, 7. CERobs Consulting, LLC, 8. Urovant Sciences
KEYWORDS: Clinical Trial, Incontinence, Overactive Bladder, Voiding Dysfunction
Reductions in bothersome symptoms of frequent micturitions, urgency episodes, and urge urinary incontinence episodes are generally reported to demonstrate improvement in clinical trials for overactive bladder (OAB), but the interpretation and meaningfulness of the magnitude of the reduction for each symptom is often omitted. In the phase 3 EMPOWUR trial, once-daily vibegron 75 mg was associated with significant improvement from baseline at week 12 in average daily number of micturitions, urgency episodes, and urge urinary incontinence episodes vs placebo (P0.01, each). These analyses used a classic, anchor-based approach to interpret the meaningfulness of change in micturitions, urgency episodes, and urge urinary incontinence episodes based on the patient global impression of change (PGI-C) and predefined responder definitions.