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Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)

RecruitingPhase 3

Sponsor: University of Aarhus

Conditions: Urinary Incontinence in Children

Interventions: Solifenacin, Mirabegron

Countries: Denmark

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 overview

Sex: ALL

Age: 5 Years to 14 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
2. Age 5 to 14 years (inclusive) at the time of inclusion.
3. Overactive bladder as per International Children's Continence Society criteria
4. At least 2 daytime urinary incontinence episodes per week
5. Inadequate effect of at least 4 weeks urotherapy (non-pharmacological treatment)
6. No previous treatment with solifenacin, mirabegron or bladder/sphincter botulinum toxin injections
7. No current constipation as per ROME IV criteria or fecal incontinence (laxative treatment is accepted)
8. Per investigator's judgment, the participant can swallow or can learn to swallow study medication

Exclusion Criteria:

1. Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information
2. Known or suspected hypersensitivity to study medication
3. Any contraindication to the use of the study medication
4. Known urogenital anatomical abnormalities affecting lower urinary tract function
5. Known kidney or bladder stones
6. Known diabetes insipidus
7. Ongoing symptomatic urinary tract infection
8. Recurrent urinary tract infection or ongoing prophylactic antibiotic treatment
9. Known QTc prolongation, QTc \>460 ms, or risk of QTc prolongation (hypokalaemia, exercise-induced syncope, or familial long QT syndrome)
10. Other significant electrocardiogram abnormalities
11. Known hypertension
12. ≤3 daily voiding, evaluated by 48-hour frequency-volume chart
13. Uroflowmetry suggestive of other pathology than overactive bladder (staccato-shaped, interrupted-shaped, or plateau-shaped curve)
14. Post-void residual \>50 ml after double voiding
15. Dipstick haematuria (≥2+ erythrocytes) or macroscopic haematuria
16. Pregnancy or breastfeeding
17. Female subjects of childbearing potential
18. Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence
19. Inability to swallow study medication
20. Use of any medication during study period, except permitted medication

Locations (5)

Aalborg, Aalborg, Denmark
Aarhus, Aarhus N, Denmark
Esbjerg, Esbjerg, Denmark
Herning, Herning, Denmark
Kolding, Kolding, Denmark