Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry): Protocol for an Open-Label Prospective Randomized Trial.

Background: To the best of our knowledge, no studies have investigated the withdrawal strategy of pharmacological treatment with solifenacin or mirabegron in children diagnosed with urinary incontinence who have achieved continence on pharmacotherapy.

Objective: The primary objective is to investigate if abrupt withdrawal versus gradual withdrawal of pharmacotherapy (solifenacin or mirabegron) influences the risk of recurrence of incontinence, assessed by a self-reported 14-day calendar of incontinence episodes.

Methods: Children aged 5-14 years diagnosed with urinary incontinence, treated with pharmacotherapy of solifenacin 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 the recurrence of incontinence after withdrawal, 1 month after initiation of withdrawal of the physician-prescribed medication, assessed by a self-reported 14-day calendar of incontinence episodes. In addition, recurrence of incontinence after 3, 6, and 12 months after initiation of withdrawal will be measured. The hypothesis that gradual withdrawal is superior to abrupt withdrawal regarding the risk of recurrence of incontinence will be analyzed by logistic regression.

Results: Recruitment began at the end of May 2024 and will continue until 216 patients are included, which is expected by December 2027. As of February 2025, a total of 25 participants are included.

Conclusions: The results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin or mirabegron in children with daytime urinary incontinence.

Trial registration: ClinicalTrials.gov NCT06465576; https://clinicaltrials.gov/search?term=NCT06465576.

International registered report identifier (irrid): DERR1-10.2196/63226.