Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children with Overactive Bladder and Daytime Urinary Incontinence (BeDry)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 14
Healthy Volunteers: f
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• 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
Locations
Other Locations
Denmark
Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
RECRUITING
Aalborg
Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
RECRUITING
Aarhus
Department of Pediatric and Adolescent medicine, Esbjerg Hospital
RECRUITING
Esbjerg
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
RECRUITING
Herning
Department of Pediatric and Adolescent Medicine, Kolding Hospital