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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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06465576). StuddyBuddy aggregates publicly available trial information.