Strategy for withdrawal of pharmacological treatment for urinary incontinence in children (StayDry): Protocol for an open-label prospective randomized trial (Preprint)

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. 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 and up to 12 months follow-up, assessed by 14-day calendar of incontinence episodes. RESULTS Participants will be recruited from May 2024 to December 2027. CONCLUSIONS The results are expected to influence the withdrawal strategy of pharmacological treatment with solifenacin and/or mirabegron in children with daytime urinary incontinence. CLINICALTRIAL EU CT 2023-510280-35-00.