← Back to all trials
Active Not Recruiting
NCT06465576
Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
Conditions: Urinary Incontinence in Children
Sex: All
Ages: 5 Years – 14 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 216
Sponsor: University of Aarhus
Location: Department of Pediatric and Adolescent Medicine, Aalborg University Hospital Aalborg Aalborg
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 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 signing the consent and inclusion.
3. Diagnose with urinary incontinence as per ICCS criteria.
4. Pharmacological treatment with solifenacin and/or mirabegron.
5. Continence has been achieved on pharmacological therapy with solifenacin and/or mirabegron.
6. Previously withdrawal attempts are accepted.
7. Continence remained on the same dosage of medication for a minimum of three months.
Exclusion Criteria:
1. Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information.
2. Neurogenic detrusor overactivity (neurogenic bladder)
Source: ClinicalTrials.gov (NCT06465576). StuddyBuddy aggregates publicly available trial information.