Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)

Launched by UNIVERSITY OF AARHUS · Jun 13, 2024

Keywords

ClinConnect Summary

The StayDry clinical trial is looking at the best way to stop medication for children with urinary incontinence, which is when a child has trouble controlling their bladder. The study will compare two methods: stopping the medication all at once (abrupt withdrawal) versus slowly reducing the medication over time (gradual withdrawal). Researchers want to see if either method affects the chances of the child experiencing incontinence again after stopping the medicine.

To be part of this trial, children aged 5 to 14 who have been diagnosed with urinary incontinence and have been taking medications called solifenacin or mirabegron are eligible. It’s important that these children have been able to control their incontinence while on medication for at least three months. Parents or guardians will need to give their consent for the child to participate. If a child joins the study, they will be randomly assigned to one of the two withdrawal methods, and the study is currently recruiting participants. This trial aims to help improve the treatment process for children dealing with urinary incontinence.

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 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)