Efficacy and Safety of Mirabegron Compared to Solifenacin in Treatment of Non-neurogenic Overactive Bladder in Children: A Randomized Controlled Trial
Abstract
ABSTRACT Purpose: Non-neurogenic overactive bladder (OAB) is a common problem in children. Antimuscarinics have been widely used as first-line medical treatment. However, their frequent side effects necessitate searching for therapeutic alternatives. We aimed to assess the efficacy and safety of the beta 3 agonist, mirabegron. Materials and Methods: A randomized controlled trial enrolled child with non-neurogenic OAB refractory to behavioral urotherapy. Patients were randomized to receive either Mirabegron 25/50 mg based on a 40-kg body weight cutoff or solifenacin 5 mg for 12 weeks. Patients were assessed using Dysfunctional Voiding Scoring System questionnaire (DVSS), 3-day voiding diary and uroflowmetry. Vital signs and adverse effects were recorded at baseline and follow-up. The study primary endpoint was ≥50% reduction of the baseline DVSS. Results: Among 128 patients screened, 72 patients (36 in each group) completed the study with a mean age of 9.2±2.3 years. Both groups had significant improvement of DVSS and voiding diary (p<0.001) at 12 weeks. In mirabegron group, 94.4% (34/36) had greater than 50% improvement of DVSS compared to 75% (27/36) of solifenacin group (P=0.02). Complete symptom resolution was observed in 22.2% (8/36) patients on mirabegron versus 8.3% (3/36) on solifenacin (P=0.1). Patients on mirabegron had less adverse effects (19.4% vs 47.2%; p=0.01). Conclusion: Mirabegron is more effective with fewer adverse effects than solifenacin for treatment of…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 128 participants or records.
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