Evaluating Sexual Function in Men Treated With Vibegron for Overactive Bladder While on Pharmacological Therapy For Benign Prostatic Hyperplasia: Exploratory Analysis From the Phase 3 COURAGE Trial

Document Type

Conference Proceeding

Publication Date

5-2026

Publication Title

Journal of Urology

Abstract

INTRODUCTION AND OBJECTIVES: Sexual dysfunction is a common but under-recognized concern for male patients with overactive bladder (OAB) and benign prostate hyperplasia (BPH), contributing to impaired quality of life and sexual function. Pharmacologic treatments for BPH and OAB may also influence sexual function. The phase 3 COURAGE trial demonstrated that treatment with vibegron, a selective β3-agonist, led to significant and clinically meaningful improvements in OAB symptoms and health-related QoL. Because β3 receptors are present in corporal (penile erectile) tissue, we performed exploratory analyses to assess if sexual function is affected by the addition of vibegron to ongoing therapies for men with OAB on treatment for BPH. METHODS: COURAGE (NCT03902080) was a phase 3,double-blind, placebo-controlled trial. Men aged ≥45 years with OAB and BPH receiving α-blocker ± 5α-reductase inhibitors were randomized 1:1 to once-daily vibegron 75 mg or placebo for 24 weeks. Sexual function assessments included change from baseline (CFB) to week 24 in the International Index of Erectile Function (IIEF) domain scores and overall satisfaction score. The International Prostate Symptom Score (IPSS) QoL score and adverse events (AEs) related to sexual function were also assessed. RESULTS: Overall, 919 patients (vibegron, n=462; placebo, n=457) had evaluable CFB in IIEF scores at week 24. All domain scores and overall satisfaction scores were similar between treatment groups at baseline and remained similar after treatment. At week 24, mean(SD) CFB for vibegron vs placebo were: erectile function, -1.3 (7.0) vs -1.1 (6.8); orgasmic function, -0.5 (3.2) vs -0.5 (3.5); sexual desire, -0.0 (2.0) vs 0.1 (2.1); intercourse satisfaction, -0.6 (3.4) vs -0.6 (3.5); overall satisfaction, -0.4 (2.3) vs -0.4 (2.5). IPSS QoL scores were also similar between treatment groups at both baseline (mean [SD]: 4.4 [1.1] vs 4.4 [1.1] for vibegron and placebo, respectively) and aftertreatment. Week 24 mean (SD) CFB was -1.7 (1.7) for vibegron vs -1.2 (1.5) for placebo. Overall, the incidence of AEs related to sexual function was low for both treatment groups; erectile dysfunction (0.7%vs 0.2%) and prostatitis (0.2% vs 0.2%) were the most common AEs associated with reproductive function. CONCLUSIONS: No clinical effect on sexual function as assessed via IIEF or IPSS QoL was observed with vibegron treatment. Although the presence of β3 receptors in corporal tissue may promote corporal relaxation, there was no discernible clinical augmentation or diminution of erectile function. Further research on β3 agonists utilizing erectile dysfunction as the primary outcome is recommended.

Volume

215

Issue

5S

First Page

e1457

Last Page

e1457

Comments

American Urological Association Annual Meeting, May 15-18, 2026, Washington, DC

DOI

10.1097/01.JU.0001191720.97092.ae.08

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