StayDry

Phase 1

Recruiting

Conditions: Daytime urinary incontinence
MedDRA version: 20.0Level: LLTClassification code: 10008523Term: Childhood incontinence Class: 10038359
MedDRA version: 21.1Level: LLTClassification code: 10021642Term: Incontinence of urine Class: 10038359
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

Registration Number: CTIS2023-510280-35-00

Lead Sponsor: Region Midtjylland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 216

Inclusion Criteria

The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation any study specific procedures., Age 5 to 14 years (inclusive) at the time of signing the consent., 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.

Exclusion Criteria

Neurogenic detrusor overactivity (neurogenic bladder)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to investigate if abrupt withdrawal versus phased withdrawal of pharmacotherapy (solifenacin and/or mirabegron) influences the risk of recurrence of incontinence.;Secondary Objective: The secondary objective is to evaluate whether abrupt and/or phased termination is associated with any type of withdrawal syndrome involving other symptoms than incontinence. Furthermore, the effect of treatment on well-being and quality of life.;Primary end point(s): 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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Secondary outcome measures are development of any withdrawal symptoms, assessed by questionnaire on withdrawal symptoms (Appendix 2), change from baseline up to 44 days after initiation of withdrawal.