Efficacy and Safety of Mirabegron in Males with Overactive Bladder and Lower Urinary Tract Symptoms: Analysis from an Integrated Database

Eur Urol Open Sci. 2025 Oct 31;82:91-99. doi: 10.1016/j.euros.2025.10.001. eCollection 2025 Dec.

ABSTRACT

BACKGROUND AND OBJECTIVE: Several phase 2-4 studies have investigated mirabegron for treating patients with overactive bladder (OAB). The objective of this study was to evaluate the efficacy and safety of mirabegron in adult male OAB patients with or without benign prostate enlargement (BPE) receiving medications for lower urinary tract symptoms (LUTS) management.

METHODS: A post hoc analysis of 13 phase 2-4 studies using mirabegron (2- or 4-wk single-blind placebo run-in followed by 12-wk double-blind treatment period) was conducted. The studies had four treatment arms-(1) mirabegron beginning with 25 mg and then escalated to 50 mg (25/50 mg), (2) mirabegron 50 mg, (3) mirabegron 25/50 mg + tamsulosin hydrochloride (HCl) 0.4 mg, and (4) mirabegron 50 mg + tamsulosin HCl 0.2 mg, and three cohorts-cohort 1, OAB males overall; cohort 2, OAB males with concomitant BPE taking alpha blockers; and cohort 3, OAB males with concomitant BPE taking other LUTS medications (not alpha blockers). The primary efficacy endpoints were change from baseline to 12 wk in the mean daily number of micturitions and mean daily number of incontinence episodes. The secondary endpoints included safety, tolerability, and measures of OAB derived from the daily micturition diary, and patient-reported outcomes of voiding and storage.

KEY FINDINGS AND LIMITATIONS: These results showed improvement in the primary and most secondary endpoints. Participants taking alpha blockers and mirabegron had increased volume voided per micturition. Safety results were consistent with the known profile of mirabegron. Outcomes should be interpreted with caution, as there were few participants taking other LUTS medications.

CONCLUSIONS AND CLINICAL IMPLICATIONS: Results showed that mirabegron is effective and safe in male OAB patients, with or without BPE or receiving medications for LUTS management.

PATIENT SUMMARY: We conducted a combined analysis of 13 studies of mirabegron in males with overactive bladder with or without benign prostate enlargement. The analyzed patients included those taking mirabegron and mirabegron combined with other medications for lower urinary tract symptoms. Our results showed that mirabegron was safe and effective in reducing the symptoms of overactive bladder.

PMID:41246035 | PMC:PMC12617816 | DOI:10.1016/j.euros.2025.10.001