Evaluating treatments for daytime urinary incontinence in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of combination therapy using solifenacin and mirabegron compared to high-dose monotherapy of each medication in treating daytime urinary incontinence in children aged 5 to 14 years. A total of 236 children who have not fully responded to previous treatments will be randomly assigned to one of four treatment groups for an 18-week period. The study will also evaluate the safety, tolerability, and impact on quality of life associated with these treatments. The design is multicenter, randomized, and single-blinded to ensure robust results.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
  Aalborg, Aalborg, Denmark Recruiting
• Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
  Aarhus, Aarhus N, Denmark Recruiting
• Department of Pediatric and Adolescent medicine, Esbjerg Hospital
  Esbjerg, Esbjerg, Denmark Recruiting
• Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
  Herning, Herning, Denmark Recruiting
• Department of Pediatric and Adolescent Medicine, Kolding Hospital
  Kolding, Kolding, Denmark Recruiting

Study contacts

• Study coordinator: Ann-Kristine Mandøe Svendsen, MD
• Email: ankrso@rm.dk
• Phone: +45 78430408

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.