Year: 2025 | Month: October-December | Volume: 10 | Issue: 4 | Pages: 116-124
DOI: https://doi.org/10.52403/ijshr.20250417
Therapeutic Outcomes of Solifenacin, Mirabegron, and Their Combination in Overactive Bladder: A Comparative Analysis
Kumar Gaurav1, Mukesh Kumar1, Santosh Kumar1, Priyanka Kumari1, Arun Kumar1, Asha Singh2
1Tutor/Senior Resident, 2Professor & Head,
Department of Pharmacology, Nalanda Medical College, Patna, Bihar, India
Corresponding Author: Arun Kumar
ABSTRACT
Background: Overactive bladder (OAB) is a common and distressing condition characterized by urgency, frequency, nocturia, and incontinence, significantly impairing quality of life. Pharmacological management typically involves antimuscarinic agents or β3-adrenoceptor agonists, but monotherapy is often limited by tolerability or incomplete efficacy. Combination therapy with solifenacin and mirabegron offers complementary mechanisms of action, potentially enhancing symptom control while maintaining safety.
Methods: This prospective, randomized, comparative clinical trial enrolled 105 patients with clinically diagnosed OAB, randomized into three groups: solifenacin 5 mg daily (Group S), mirabegron 50 mg daily (Group M), and combination therapy (Group S+M). Patients were followed for 24 weeks, with assessments at baseline, 4, 12, and 24 weeks. Primary outcomes included changes in micturition frequency, urgency, incontinence, urge incontinence, and nocturia episodes per 24 hours. Secondary outcomes included treatment response, side effect profiles, and tolerability. Statistical analyses employed ANOVA, chi-square, and repeated measures ANOVA.
Results: By week 4, significant improvements were observed, with Group S+M showing the greatest reduction in micturition scores (p=0.0179). At weeks 12 and 24, combination therapy consistently outperformed monotherapies across all symptom domains (p<0.0001). Adverse events were most frequent in Group S (anticholinergic side effects), while Group M showed minimal cardiovascular effects. Group S+M demonstrated superior efficacy without a cumulative increase in side effects.
Conclusion: Combination therapy with solifenacin and mirabegron provides superior and sustained improvement in OAB symptoms compared to monotherapy, with an acceptable safety profile.
Keywords: Overactive bladder, Solifenacin, Mirabegron, Combination therapy, Urinary urgency, Nocturia, Incontinence