Vibegron Had No Impact on Sexual Function in Men with Benign Prostatic Hyperplasia

Adding vibegron to first-line therapy for benign prostatic hyperplasia (BPH) may be a safe option for men looking to preserve sexual function, according to exploratory data from the phase 3 COURAGE trial, presented at the 2026 Annual Meeting of the American Urological Association (AUA 2026) in Washington, D.C. The analyses demonstrated that adding once-daily vibegron (75 mg) to stable pharmacological therapy has no clinically meaningful effect on male sexual function. 

Sexual dysfunction is a prevalent yet often overlooked issue for men who experience overactive bladder (OAB) symptoms secondary to BPH, leading to diminished quality of life and sexual performance. While pharmacological therapies for BPH can relieve OAB symptoms, they can also cause sexual dysfunction. Vibegron, a selective beta 3-adrenergic receptor agonist, has been approved for the treatment of OAB symptoms in adults treated with first-line pharmacotherapy for BPH. While the clinical data regarding its direct impact on sexual function continue to emerge, its ability to act on beta 3 receptors in penile tissue has raised questions about its role in men struggling with both OAB and erectile dysfunction. 

The COURAGE trial was designed to evaluate the safety and efficacy of vibegron for the treatment of residual urinary symptoms in men aged 45 years and older who were receiving alpha-blockers with or without 5-alpha reductase inhibitors for BPH. The study showed that once-daily vibegron (75 mg) significantly and safely improved standard overactive bladder symptoms (such as urgency, micturition, and urge urinary incontinence) and health-related quality of life compared to placebo. 

Among other metrics in the study, the researchers assessed sexual function using validated scoring tools, including the International Index of Erectile Function (IIEF) and International Prostate Symptom Scores (IPSS). The exploratory analyses presented at AUA 2026, which included around 900 participants, showed that mean changes from baseline to week 24 were nearly identical between the vibegron and placebo groups across all domains (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction).   

The incidence of sexual function-related adverse events was very low and comparable between both treatment arms, with erectile dysfunction reported in 0.7% of the patients who received vibegron and in 0.2% of the individuals who received placebo.

“No clinical effect on sexual function as assessed via IIEF or IPSS QoL was observed with vibegron treatment,” the authors said. “Although the presence of beta 3 receptors in corporal tissue may promote corporal relaxation, there was no discernible clinical augmentation or diminution of erectile function. Further research on beta 3 agonists utilizing erectile dysfunction as the primary outcome is recommended.”