Status:
RECRUITING
Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
Lead Sponsor:
University of Aarhus
Conditions:
Urinary Incontinence in Children
Eligibility:
All Genders
5-14 years
Phase:
PHASE3
Brief 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 mira...
Detailed Description
Background: According to International Children's Continence Society, first-line treatment of children with daytime urinary incontinence is standard urotherapy, eventually followed by pharmacotherapy ...
Eligibility Criteria
Inclusion
- 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
- 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
- Known kidney or bladder stones
- Known diabetes insipidus
- Ongoing symptomatic urinary tract infection
- Recurrent urinary tract infection or ongoing prophylactic antibiotic treatment
- Known QTc prolongation, QTc \>460 ms, or risk of QTc prolongation (hypokalaemia, exercise-induced syncope, or familial long QT syndrome)
- Other significant electrocardiogram abnormalities
- Known hypertension
- ≤3 daily voiding, evaluated by 48-hour frequency-volume chart
- Uroflowmetry suggestive of other pathology than overactive bladder (staccato-shaped, interrupted-shaped, or plateau-shaped curve)
- Post-void residual \>50 ml after double voiding
- Dipstick haematuria (≥2+ erythrocytes) or macroscopic haematuria
- Pregnancy or breastfeeding
- Female subjects of childbearing potential
- Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence
- Inability to swallow study medication
- Use of any medication during study period, except permitted medication
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT06551246
Start Date
June 27 2024
End Date
December 1 2027
Last Update
December 15 2025
Active Locations (5)
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1
Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
Aalborg, Aalborg, Denmark, 9000
2
Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
3
Department of Pediatric and Adolescent medicine, Esbjerg Hospital
Esbjerg, Esbjerg, Denmark, 6700
4
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
Herning, Herning, Denmark, 7400