In the treatment of overactive bladder (OAB) in children, mirabegron demonstrates efficacy similar to that of solifenacin but has a better safety profile, according to a meta-analysis presented at the annual EAU Congress.
Pooled data from three studies showed no significant difference in treatment response—defined as a >50-percent symptom improvement in two studies and at least a 90-percent improvement in the third—between mirabegron and solifenacin (risk ratio [RR], 1.11, 95 percent confidence interval [CI], 0.92–1.33; p=0.28; I²=58.1 percent), reported senior investigator Dr Ahmed Badr from the Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK. [EAU 2026, abstract A0191]
However, in a sensitivity analysis that excluded one trial with a high risk of bias, treatment response appeared to be markedly higher with mirabegron vs solifenacin (RR, 1.24, 95 percent CI, 1.04–1.47; p=0.02; I²=0 percent), Badr added.
As for safety, mirabegron was associated with significantly fewer adverse events compared with solifenacin (RR, 0.44, 95 percent CI, 0.28–0.70; p<0.001; I²=0 percent).
The findings support the role of the β3-adrenoceptor agonist mirabegron as a potentially safer therapeutic option in paediatric OAB, according to Badr.
Antimuscarinics are the current mainstay of treatment but are limited by systemic adverse effects, he noted. Having an alternative option with better tolerability profile is crucial given that “OAB affects between 5 percent and 12 percent of children and is characterized by urgency, frequency, and incontinence, often resulting in psychosocial burden.”
The meta-analysis included two randomized clinical trials and one observational study in which the efficacy and safety of mirabegron and solifenacin were directly compared in patients aged ≤18 years with non-neurogenic OAB. A total of 246 patients were involved, among whom 116 were treated with mirabegron and 130 received solifenacin.
Badr highlighted the need for more large-scale, high-quality trials to confirm the findings and evaluate their impact on long-term clinical outcomes.
Single-centre retrospective study
A single-centre retrospective study presented at the conference yielded results consistent with that of the meta-analysis.
In a cohort of 130 paediatric patients (mean age 8.8 years, 53.8 percent male) with non-neurogenic OAB, those treated with mirabegron (n=31) showed significant symptom improvements similar to those observed in patients who received anticholinergics such as solifenacin or propiverine (n=99), reported lead researcher Dr Jae Min Chung from Pusan National University Yangsan Hospital, Yangsan, South Korea. [EAU 2026, abstract A0226]
Voided volume on uroflowmetry improved for 67.7 percent of patients on mirabegron vs 57.6 percent of those on anticholinergics (p=0.315), Chung noted.
Adverse effects occurred in 9.7 percent of patients in the mirabegron group and 10.1 percent of those in the anticholinergic group (p=0.028).
All three patients who experienced adverse effects in the mirabegron group reported difficult voiding. Meanwhile, the AEs reported by 10 patients in the anticholinergic group included difficult voiding, dysuria, headache, nausea, interrupted void, constipation, or residual urine sensation.
“All symptoms were mild, and there was no case of drug discontinuation,” Chung noted.
These data indicate that “mirabegron is as effective and safe as anticholinergics in the management of OAB in children,” he said. “Given its comparable efficacy and tolerability, mirabegron may be a valuable alternative for children who have tolerability issues with anticholinergics.”