Ann-Kristine Mandøe Svendsen

Regionshospitalet Herning

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Luise Borch

Regionshospitalet Herning

Konstantinos Kamperis

Aarhus University Hospital

Anne Estrup Olesen

Aalborg University Hospital

Kristina Thorsteinsson

Steno Diabetes Centers

Søren Hagstrøm

Aalborg University

Mads Arvad

Regionshospitalet Herning

Søren Hagstroem

Aalborg University Hospital

Nanna Celina Henneberg

Aalborg University

Anna Elizabeth Rhode Andersen

Aalborg University

Cooperative Institutions

Aalborg University

Aalborg University Hospital

Aarhus University Hospital

Aarhus University

Regionshospitalet Herning

Steno Diabetes Centers

Glostrup Hospital

Regional Hospital West Jutland

North Denmark Region

Mech-Sense

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

Ann-Kristine Mandøe Svendsen Søren Hagstrøm Konstantinos Kamperis Anna Elizabeth Rhode Andersen Nanna Celina Henneberg

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.

Solifenacin

Mirabegron

Pharmacotherapy

10.2196/preprints.63226

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The effect of methylphenidate for giggle incontinence in children

Neurourology and Urodynamics (2023)

Ann-Kristine Mandøe Svendsen Konstantinos Kamperis Søren Hagstroem Kristina Thorsteinsson Mads Arvad

Abstract Introduction Giggle incontinence (GI) is a rare form of urinary incontinence that occurs during or immediately after laughing due to involuntary and complete bladder emptying. Few studies in the literature report that methylphenidate can be effective in treatment of this condition. Objective The aim of this study is to characterize children with GI and evaluate their response to methylphenidate, as well as describe treatment duration, dosage of methylphenidate, relapse rates after discontinuation of medication, and side effects. Methods Medical records and 48‐h frequency‐volume charts from children treated with methylphenidate for GI in the period January 2011–July 2021 were retrospectively analyzed. Results Eighteen children were diagnosed with GI and fulfilled inclusion criteria. Fifteen patients were included in analysis, as 3 out of 18 children decided not to take the methylphenidate that was prescribed. In total, 14 out of the 15 GI patients treated with methylphenidate experienced clinical effect. All patients included in the study had methylphenidate prescribed in a dose range of 5–20 mg daily. Treatment duration ranged from 30 to 1001 days, with a median of 152 days (IQR 114, 243.5). Ten children experienced complete response and two of those reported symptom relapse after discontinuation of the methylphenidate. Only mild and short‐lasting side effects were reported by two patients. Discussion Our study demonstrates that methylphenidate is an effective treatment in children diagnosed with GI. Side effects are mild and uncommon.

Discontinuation

10.1002/nau.25232

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Efficacy of solifenacin, mirabegron and combination therapy in children with daytime urinary incontinence (BeDry): Protocol for a randomized single-blinded controlled trial (Preprint)

Ann-Kristine Mandøe Svendsen Søren Hagstrøm Kristina Thorsteinsson Konstantinos Kamperis Anne Estrup Olesen

BACKGROUND According to International Children’s Continence Society (ICCS), first-line treatment of children with daytime urinary incontinence is standard urotherapy, eventually followed by pharmacotherapy of anticholinergics. The effect of medical treatment is sparsely investigated and primarily in non-randomized trials. OBJECTIVE The primary objective is to evaluate if (1) combination therapy of solifenacin and mirabegron in low doses is superior to monotherapy of solifenacin in high dose and if (2) combination therapy of mirabegron and solifenacin in low doses is superior to monotherapy of mirabegron in high dose in treatment of daytime urinary incontinence among children aged 5 to 14 years who are none complete responders to respectively monotherapy of solifenacin in low dose or monotherapy of mirabegron in low dose. The secondary objective is to evaluate the treatment response of combination therapy of solifenacin and mirabegron in low doses, monotherapy in high dose and monotherapy in low doses as supplementary comparisons. Additionally, the secondary objective is to evaluate side effects, safety, and tolerability of the medical treatment as well as the effect of treatment on well-being and quality of life. METHODS Children aged 5-14 years diagnosed with daytime urinary incontinence refractory to standard urotherapy will be randomized to four treatment groups, randomization 1:1:1:1. Initially two groups will receive solifenacin 5 mg and two groups will receive mirabegron 25 mg. After 6 weeks, non-complete respondsers will receive add-on treatment according to their primary randomization group; group 1A will reviece solifenacin 5 mg and add-on solifenacin 5 mg, group 1B will receive solifenacin 5 mg and add-on mirabegron 25 mg, group 2A will receive mirabegron 25 mg and add-on mirabegron 25 mg, group 2B will receive mirabegron 25 mg and add-on solifenacin 5 mg. Total treatment period will be 18 weeks. The primary endpoint measure is treatment response assessed by change from visit 2 to end of study, according to number of wet days pr. 7 days by DryPie. RESULTS Participants will be included from June 2024 to December 2027. CONCLUSIONS The trial has the potential to optimize medical treatment of children with daytime urinary incontinence, to shorten the treatment period, diminish side effects and minimized unnecessary medical expenses. CLINICALTRIAL EU CT 2023-510187-13-00

Mirabegron

Solifenacin

Preprint

Double blinded

10.2196/preprints.63588

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