Vibegron add-on therapy is both safe and effective for men with persistent storage symptoms after taking alpha-1 blockers or a phosphodiesterase type 5 (PDE5) inhibitor for benign prostatic hyperplasia (BPH), according to preliminary findings.

A total of 42 patients had an Overactive Bladder Symptom Score (OABSS) of 3 or more along with symptoms of frequency or urgency despite use of a BPH medication. Over 12 weeks, the addition of vibegron 50 mg once daily significantly reduced their total OABSS from 6.21 to 4.38, Keisuke Ishikawa, MD, of Juntendo University in Tokyo, Japan, and colleagues reported in Urology. In addition, investigators found significant improvements in responses to many questions on the OABSS, International Prostate Symptom Score (IPSS), Core Lower Urinary Tract Symptom (CLSS), and Quality of Life Index over 12 weeks, whether patients were taking concomitant alpha-1 blockers or a PDE5 inhibitor. As expected, patients reported no meaningful improvements in stress incontinence, straining, bladder pain, and urethral pain on the CLSS.

Maximum flow rate and residual urine volume did not change during the study. None of the patients discontinued vibegron therapy due to treatment emergent adverse events (TEAEs).

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The investigators identified OABSS, CLSS, prostate volume, and alpha-1 blocker monotherapy as independent factors affecting the efficacy of vibegron, a selective beta3-adrenergic receptor agonist.

“Taken together, the lack of TEAEs with unchanged residual urine volume indicate that vibegron add-on therapy added to monotherapy with α-1 blockers or a PDE5 inhibitor is quite safe for patients with BPH and persistent storage symptoms,” Dr Ishikawa’s team concluded. “Further long-term, controlled, randomized clinical trials with a placebo arm in a larger number of patients are needed.”


Ishikawa K, Tsujimura A, Miyoshi M, et al. Efficacy and safety of vibegron add-on therapy in men with persistent storage symptoms after receiving alpha 1-blocker or phosphodiesterase 5 inhibitor: a preliminary study. Published online January 20, 2021. Urology. doi:10.1016/j.urology.2021.01.021