Long-term efficacy and safety of solifenacin, mirabegron, and their combination for overactive bladder: a systematic review
Abstract
Background: Current clinical guidelines recommend either muscarinic receptor antagonists or β3-adrenoceptor agonists for overactive bladder (OAB) treatment. These recommendations, however, are primarily based on short-term (12-week) clinical trials, leaving a critical gap in evidence regarding their long-term (≥1 year) efficacy and safety. Moreover, the long-term evidence synthesized here is limited to solifenacin and mirabegron, and its generalizability to other agents remains uncertain.
Objective: To systematically compare the long-term efficacy and safety of solifenacin monotherapy, mirabegron monotherapy, and their combination in patients with OAB.
Methods: We systematically searched PubMed, Embase, Cochrane Library, Scopus, and ClinicalTrials.gov for clinical studies published from inception to 2 April 2026. Two reviewers independently screened, selected, and extracted data. Methodological quality was assessed using the Jadad scale and the Cochrane Risk of Bias 2 (ROB 2) tool. The primary outcomes were changes from baseline in mean volume voided incontinence episodes per 24 h, and micturition frequency per 24 h. The secondary outcome was the incidence of treatment-related adverse drug reactions Quantitative meta-analysis was performed only for safety outcomes using a random-effects model. For the primary efficacy outcomes, substantial heterogeneity (I2>58%) across the included studies precluded meaningful pooling, therefore, a narrative synthesis of efficacy data was…
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