RecruitingPhase 3NCT06551246

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Overactive Bladder and Daytime Urinary Incontinence (BeDry)


Sponsor

University of Aarhus

Enrollment

236 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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. In total, 236 children diagnosed with daytime urinary incontinence will be randomized 1:1:1:1 to one of four treatment groups. Total pharmacological treatment period will be 18 weeks.


Eligibility

Min Age: 5 YearsMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Mirabegron and a drug called Solifenacin for people with urinary incontinence in children. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSolifenacin

According to randomization.

DRUGMirabegron

According to randomization.


Locations(5)

Department of Pediatric and Adolescent Medicine, Aalborg University Hospital

Aalborg, Aalborg, Denmark

Department of Pediatric and Adolescent Medicine, Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Department of Pediatric and Adolescent medicine, Esbjerg Hospital

Esbjerg, Esbjerg, Denmark

Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Herning, Herning, Denmark

Department of Pediatric and Adolescent Medicine, Kolding Hospital

Kolding, Kolding, Denmark

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NCT06551246


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