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

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.

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.

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%).

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.

Not applicable.

The online version contains supplementary material available at 10.1186/s12894-026-02155-9.

BMC urology. 2026 Apr 18*** epublish ***

Mostafa Shaheen, Omar Mohamed Ali, Abdullah A Draz, Amro K Barakat, Ahmed Elghattas, Toqa Elbaz, Iyad Walid, Tasnim Tarboush, Asmaa Elsayed, Tasneem Mahmoud, Esraa Mohamed Elkhateeb, Abdallah Adel Nofal, Emad Samaan

Faculty of Medicine, Mansoura University, Mansoura, 35516, Egypt. ., Faculty of Medicine, Mansoura University, Mansoura, 35516, Egypt., Department of Internal Medicine - Nephrology Unit, Mansoura University Hospitals, Mansoura, Egypt.