The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose.
In total, 236 children diagnosed with daytime urinary incontinence will be randomized 1:1:1:1 to one of four treatment groups. Total pharmacological treatment period will be 18 weeks.
The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
Age 5 to 14 years (inclusive) at the time of inclusion.
Overactive bladder as per International Children's Continence Society criteria
At least 2 daytime urinary incontinence episodes per week
Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information
Known or suspected hypersensitivity to study medication
Any contraindication to the use of the study medication
Known urogenital anatomical abnormalities affecting lower urinary tract function