Evaluating treatments for daytime urinary incontinence in children

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

This study is testing if a combination of two medications can help children aged 5 to 14 with daytime urinary incontinence feel better compared to taking each medication alone.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 236 (estimated)
• Ages: 5 Years to 14 Years
• Sex: All
• Sponsor: University of Aarhus (other)
• Locations: 5 sites (Aalborg, Aalborg and 4 other locations)
• Trial ID: NCT06551246 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 5 to 14 years with daytime urinary incontinence who have not responded adequately to non-pharmacological treatments.

Not a fit: Patients who have previously been treated with solifenacin or mirabegron, or those with contraindications to these medications, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for children suffering from daytime urinary incontinence.

How similar studies have performed: While the treatment of daytime urinary incontinence in children has been explored, this specific combination therapy approach is novel and has not been extensively tested in prior studies.

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

Where this trial is running

Aalborg, Aalborg and 4 other locations

• 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

Conditions: Urinary Incontinence in Children, Urinary incontinence, Daytime urinary incontinence, Overactive bladder, Children, Solifenacin, Mirabegron