Efficacy and safety of mirabegron versus solifenacin in the treatment of overactive bladder in children: a systematic review and meta-analysis

Abstract

Abstract Background Overactive bladder (OAB) affects 5–12% of children and is associated with urgency, frequency, and incontinence, often leading to psychosocial distress. Antimuscarinics are widely used but limited by systemic side effects. Mirabegron, a β3-adrenoceptor agonist, may offer better tolerability. This review evaluated available evidence comparing mirabegron and solifenacin in pediatric OAB. Methods Following PRISMA guidelines (PROSPERO: CRD420251129236), we searched PubMed, Scopus, Web of Science, and the Cochrane Library through September 2025 for studies directly comparing mirabegron and solifenacin in children ≤ 18 years with non-neurogenic OAB. Two reviewers independently screened studies, extracted data, and assessed quality. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models. Results Three studies (246 children; 116 mirabegron, 130 solifenacin) met inclusion criteria. Pooled analysis showed no significant difference in treatment response between groups (RR = 1.11, 95% CI: 0.92–1.33; p = 0.28; I² = 58%). Mirabegron was associated with significantly fewer adverse events (RR = 0.44, 95% CI: 0.28–0.70; p = 0.0004; I² = 0%). Conclusions Mirabegron and solifenacin demonstrate comparable efficacy in pediatric OAB, with mirabegron suggesting a more favorable short-term safety profile. These preliminary findings require confirmation in larger, long-term trials with standardized outcome measures. Clinical Trial Registration Not applicable.