Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 14
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
RECRUITING
Aalborg
Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
RECRUITING
Aarhus
Department of Pediatric and Adolescent medicine, Esbjerg Hospital
NOT_YET_RECRUITING
Esbjerg
Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
RECRUITING
Herning
Department of Pediatric and Adolescent Medicine, Kolding Hospital
NOT_YET_RECRUITING
Kolding
Contact Information
Primary
Ann-Kristine Mandøe Svendsen, MD
ankrso@rm.dk
+45 78430408
Backup
Luise Borch, MD, PhD
luise.borch@rm.dk
+45 78433654
Time Frame
Start Date:2024-05-27
Estimated Completion Date:2027-12-01
Participants
Target number of participants:216
Treatments
Experimental: Abrupt withdrawal of solifenacin
Experimental: Gradual withdrawal of solifenacin
Experimental: Abrupt withdrawal of mirabegron
Experimental: Gradual withdrawal of mirabegron
Experimental: Abrupt withdrawal of solifenacin + mirabegron
Experimental: Gradual withdrawal of solifenacin + mirabegron