Withdrawal strategies for treating urinary incontinence in children
Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
This study is testing whether stopping medication for urinary incontinence in children all at once or gradually works better for keeping them dry.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 5 Years to 14 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 5 sites (Aalborg, Aalborg and 4 other locations) |
| Trial ID | NCT06465576 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of abrupt versus gradual withdrawal of pharmacotherapy (solifenacin and/or mirabegron) on the recurrence of urinary incontinence in children aged 5-14 years. Participants who have achieved continence on these medications will be randomized to either withdrawal strategy. The aim is to establish an evidence-based approach to safely discontinue pharmacological treatment in pediatric patients. The study seeks to fill a gap in current clinical practices regarding withdrawal strategies for these medications.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 14 years who have been diagnosed with urinary incontinence and have achieved continence while on solifenacin and/or mirabegron.
Not a fit: Patients with neurogenic detrusor overactivity or those unable to understand the study information may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a standardized approach to safely withdraw medications for urinary incontinence in children, potentially reducing recurrence rates.
How similar studies have performed: While there have been studies on withdrawal strategies for other medications in pediatric populations, this specific approach for solifenacin and mirabegron in urinary incontinence is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Aalborg, Aalborg and 4 other locations
- Department of Pediatric and Adolescent Medicine, Aalborg University Hospital — Aalborg, Aalborg, Denmark (Recruiting)
- Department of Pediatric and Adolescent Medicine, Aarhus University Hospital — Aarhus, Aarhus N, Denmark (Recruiting)
- Department of Pediatric and Adolescent medicine, Esbjerg Hospital — Esbjerg, Esbjerg, Denmark (Not_yet_recruiting)
- Department of Pediatric and Adolescent Medicine, Gødstrup Hospital — Herning, Herning, Denmark (Recruiting)
- Department of Pediatric and Adolescent Medicine, Kolding Hospital — Kolding, Kolding, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Ann-Kristine Mandøe Svendsen, MD
- Email: ankrso@rm.dk
- Phone: +45 78430408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.