Study of Low-Dose Combination Therapy Versus High-Dose Monotherapy with Solifenacin and Mirabegron in Children Aged 5 to 14 Years with Daytime Urinary Incontinence

What this Trial Is About

Researchers are studying the treatment of daytime urinary incontinence in children aged 5 to 14 years who do not fully respond to low doses of either solifenacin or mirabegron alone. The goal is to see if combining low doses of both medications works better than using a high dose of either drug by itself. This is a phase 3 clinical trial designed as a multicenter, randomized, single-blinded study involving 236 children diagnosed with this condition. Participants are randomly assigned to one of four groups. Two groups start with solifenacin 5 mg daily and two groups start with mirabegron 25 mg daily for the first 6 weeks. If children do not respond completely after 6 weeks, they receive an add-on treatment for 12 more weeks either an additional dose of the same drug or the other drug, depending on their initial group. The total treatment period lasts 18 weeks. During the study, researchers assess treatment response by tracking the number of wet days per week from week 6 through the end of the study. Additional evaluations include measuring incontinence severity, urge severity, urine volume, frequency of urination, and quality of life using questionnaires. Safety, side effects, and tolerability are also monitored. Participation involves regular visits and assessments over the full 18-week treatment period.

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)