Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 13, 2024
Open Peer Review Period: Jun 13, 2024 - Aug 8, 2024
Date Accepted: Apr 4, 2025
(closed for review but you can still tweet)
“Strategy for withdrawal of pharmacological treatment for urinary incontinence in children (StayDry): Protocol for an open-label prospective randomized trial”
ABSTRACT
Background:
To the best of our knowledge, no studies have investigated the withdrawal strategy of pharmacological treatment with solifenacin and/or mirabegron in children diagnosed with urinary incontinence that have achieved continence on pharmacotherapy.
Objective:
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, assessed by a self-reported online 14-day calendar of incontinence episodes.
Methods:
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. The primary outcome measure is recurrence of incontinence after withdrawal 1 month after initiation of withdrawal of the physician prescribed medication, assessed by a self-reported online 14-day calendar of incontinence episodes. Additionally, recurrence of incontinence after 3, 6 and 12 months after initiation of withdrawal will be measured.
Results:
Recruitment began ultimo May 2024 and will continue until 216 patients are included, which is expected by December 2027. As of January 2025, 20 participants are included.
Conclusions:
The results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin and/or mirabegron in children with daytime urinary incontinence. Clinical Trial: CTIS: EU CT 2023-510280-35-00 ClinicalTrials.gov ID: NCT06465576
Citation
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