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

Launched by UNIVERSITY OF AARHUS · Aug 12, 2024

Keywords

ClinConnect Summary

The BeDry clinical trial is studying how effective different treatments are for children aged 5 to 14 who experience daytime urinary incontinence, which means they have trouble controlling their bladder during the day. Specifically, the trial is comparing the effectiveness of two medications, solifenacin and mirabegron, both on their own and in combination. The goal is to find out if using a low dose of both medications together works better than a higher dose of just one of them. To participate, children need to have had at least two episodes of incontinence per week and must not have responded well to other non-medication treatments for at least four weeks.

If you decide to join the trial, your child will be placed in one of four treatment groups and will receive medication for a total of 18 weeks. It’s important for parents or guardians to provide consent before the study begins, and participants need to be able to swallow the study medication. The trial is currently recruiting participants, and it could be a great opportunity for families seeking effective treatment options for their child's condition.

Gender

ALL

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