Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
University of Aarhus
216 participants
May 27, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
- Age 5 to 14 years (inclusive) at the time of signing the consent and inclusion.
- Diagnose with urinary incontinence as per ICCS criteria.
- Pharmacological treatment with solifenacin and/or mirabegron.
- Continence has been achieved on pharmacological therapy with solifenacin and/or mirabegron.
- Previously withdrawal attempts are accepted.
- Continence remained on the same dosage of medication for a minimum of three months.
Exclusion Criteria2
- Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information.
- Neurogenic detrusor overactivity (neurogenic bladder)
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Interventions
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.
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.
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)
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NCT06465576