Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
NCT Number: NCT06551246
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Urinary Incontinence in Children
Interventions: DRUG: Solifenacin|DRUG: Mirabegron
Sponsor: University of Aarhus
Sex: ALL
Age: CHILD
Enrollment: 236
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2027-12-01
Locations: Department of Pediatric and Adolescent Medicine, Aarhus University Hospital, Aarhus, Aarhus N, 8200, Denmark|Department of Pediatric and Adolescent Medicine, Aalborg University Hospital, Aalborg, 9000, Denmark|Department of Pediatric and Adolescent medicine, Esbjerg Hospital, Esbjerg, 6700, Denmark|Department of Pediatric and Adolescent Medicine, Gødstrup Hospital, Herning, 7400, Denmark|Department of Pediatric and Adolescent Medicine, Kolding Hospital, Kolding, 6000, Denmark

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.

Primary Outcome Measures: Treatment response, Assesed by change in number of wetdays pr. 7 days by DryPie, From study week 6 and through study completion, an average of 18 weeks in total
Secondary Outcome Measures: Treatment response, Assesed by change in number of wetdays pr. 7 days by DryPie, From date of randomization until study completion, an average of 18 weeks in total|Inconcintnence severity score, Assesed by DryPie (scoring from 0 to 21, in which the higher score means severe incontinence), From date of randomization until study completion, an average of 18 weeks in total|Urge severity, Quantified by Bower VAS Urgency Scheme (scoring from 0 to 10, in which the higher score means servere urge), From date of randomization until study completion, an average of 18 weeks in total|Maximum voided volume (ml), 48-hour frequency-volume chart, From date of randomization until study completion, an average of 18 weeks in total|Age standardized maximum voided volume (ml), Maximum voided volume as a percent of expected bladder capacity, From date of randomization until study completion, an average of 18 weeks in total|Average voided volume (ml), 48-hour frequency-volume chart, From date of randomization until study completion, an average of 18 weeks in total|Miction frequency, 48-hour frequency-volume chart, From date of randomization until study completion, an average of 18 weeks in total|Pediatric incontinence questionnaire total score, 20-item questionnaire (scoring from 0 to 4 on a Likert scale, with a total of 80 points in which the higher score, the greater impact of urinary incontinence of quality of life), From date of randomization until study completion, an average of 18 weeks in total|WHO-5 total score, 5-item questionnaire (scoring from 0 to 5 on a Likert scale, with a total of 30 points in which the higher score, the greater impact of urinary incontinence of quality of life), From date of randomization until study completion, an average of 18 weeks in total