Actively Recruiting
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
Led by University of Aarhus · Updated on 2025-12-15
236
Participants Needed
5
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Custody holder(s) must voluntarily sign and date informed consent before any study procedures
- Age 5 to 14 years (inclusive) at inclusion
- Diagnosed with overactive bladder according to International Children's Continence Society criteria
- At least 2 daytime urinary incontinence episodes per week
- Inadequate effect of at least 4 weeks of urotherapy (non-pharmacological treatment)
- No previous treatment with solifenacin, mirabegron, or bladder/sphincter botulinum toxin injections
- No current constipation as defined by ROME IV criteria or fecal incontinence (laxative treatment allowed)
- Participant can swallow or learn to swallow study medication as judged by investigator
You will not qualify if you...
- Inability of patient or legal guardian to understand Danish written and oral information
- Known or suspected hypersensitivity to study medication
- Any contraindication to using the study medication
- Known urogenital anatomical abnormalities affecting lower urinary tract function
- Known kidney or bladder stones
- Known diabetes insipidus
- Ongoing symptomatic urinary tract infection
- Recurrent urinary tract infection or ongoing prophylactic antibiotic use
- Known QTc prolongation, QTc >460 ms, or risk of QTc prolongation (including hypokalaemia, exercise-induced syncope, familial long QT syndrome)
- Other significant electrocardiogram abnormalities
- Known hypertension
- Fewer than 3 daily voidings as per 48-hour frequency-volume chart
- Uroflowmetry showing pathology other than overactive bladder (staccato, interrupted, or plateau-shaped curve)
- Post-void residual volume >50 ml after double voiding
- Dipstick haematuria (≥2+ erythrocytes) or visible blood in urine
- Pregnancy or breastfeeding
- Female subjects of childbearing potential
- Ongoing constipation per Rome IV criteria unresponsive to medication or fecal incontinence
- Inability to swallow study medication
- Use of any medication during study period except permitted medication
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
Aalborg, Aalborg, Denmark, 9000
Actively Recruiting
2
Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
Actively Recruiting
3
Department of Pediatric and Adolescent medicine, Esbjerg Hospital
Esbjerg, Esbjerg, Denmark, 6700
Actively Recruiting
4
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
Herning, Herning, Denmark, 7400
Actively Recruiting
5
Department of Pediatric and Adolescent Medicine, Kolding Hospital
Kolding, Kolding, Denmark, 6000
Actively Recruiting
Research Team
A
Ann-Kristine Mandøe Svendsen, MD
CONTACT
L
Luise Borch, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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