Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Inco… (NCT06551246) | Clinical Trial Compass
RecruitingPhase 3
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
Denmark236 participantsStarted 2024-06-27
Plain-language summary
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.
Who can participate
Age range5 Years – 14 Years
SexALL
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Inclusion criteria
✓. 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
✓. Inadequate effect of at least 4 weeks urotherapy (non-pharmacological treatment)
✓. No previous treatment with solifenacin, mirabegron or bladder/sphincter botulinum toxin injections
✓. No current constipation as per ROME IV criteria or fecal incontinence (laxative treatment is accepted)
✓. Per investigator's judgment, the participant can swallow or can learn to swallow study medication
Exclusion criteria
✕. Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information
What they're measuring
1
Treatment response
Timeframe: From study week 6 and through study completion, an average of 18 weeks in total