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Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
Sponsor: University of Aarhus
Summary
The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence. Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin and/or mirabegron and ready for withdrawal will be randomized 1:1 to either abrupt or gradual withdrawal, according to the medical treatment that the child is receiving.
Key Details
Gender
All
Age Range
5 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2024-05-27
Completion Date
2027-12-01
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Solifenacin
Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.
Mirabegron
Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.
Solifenacin + Mirabegron
Abrupt withdrawal indicates stopping the medication on the date of withdrawal initiation. Gradual withdrawal involves taking the applied dosage of the medication every other day over a period of 14 days, with the complete cessation of the medication occurring 14 days after the gradual withdrawal process begins.
Locations (5)
Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
Aalborg, Aalborg, Denmark
Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
Aarhus, Aarhus N, Denmark
Department of Pediatric and Adolescent medicine, Esbjerg Hospital
Esbjerg, Esbjerg, Denmark
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
Herning, Herning, Denmark
Department of Pediatric and Adolescent Medicine, Kolding Hospital
Kolding, Kolding, Denmark