Vibegron Improves Quality-of-Life Measures in Patients With Overactive Bladder: Patient-Reported Outcomes From the EMPOWUR Study.

BACKGROUND: Quality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β3 -adernergic receptor agonist that showed efficacy in treatment of symptoms of OAB in the randomized, double-blind, placebo- and active-controlled phase 3 EMPOWUR trial. Here we report patient-reported QOL outcomes from the EMPOWUR trial.

METHODS: Patients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo, or tolterodine 4 mg extended release, respectively, for 12 weeks. Patients completed the OAB questionnaire (OAB-q) at baseline and at week 12 and the patient global impression (PGI) scales for severity, control, frequency, and leakage at baseline and at weeks 4, 8, and 12. Change from baseline at week 12 and responder rates (OAB-q: patients achieving a ≥10-point improvement; PGI: patients reporting best possible response) were assessed. Vibegron was compared with placebo, and no comparisons were made between vibegron and tolterodine.

RESULTS: Of the 1518 patients randomized, 1463 (placebo, n=520; vibegron, n=526; tolterodine, n=417) had evaluable data for efficacy measures and were included in the analysis. Mean baseline OAB-q and PGI scores were comparable among treatment groups. At week 12, patients receiving vibegron had greater improvements from baseline in OAB-q subscores of coping, concern, sleep, health-related QOL total, and symptom bother (P<0.01 each) compared with patients receiving placebo; a greater proportion of patients receiving vibegron versus placebo were responders in the OAB-q coping (P<0.05) and symptom bother scores (P<0.0001). Compared with placebo, a greater proportion of patients who received vibegron achieved the best response on all PGI endpoints at week 12 (P<0.05 each) and were classified as responders (P<0.05 each).

CONCLUSIONS: In the 12-week EMPOWUR trial, treatment with vibegron was associated with significantly greater and clinically meaningful improvement in OAB-q and PGI scores compared with placebo, consistent with improvements in OAB symptoms.