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Studies

Interventional Recruiting Phase 3

NCT06551246 on ClinicalTrials.gov

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

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

  • Sponsor: Aarhus University
  • Enrollment: 236 (Estimated)
  • Study start: 2024-06-27 (Actual)
  • Primary completion: 2027-10-01 (Estimated)
  • Study completion: 2027-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: 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.
  • Masking: Single (Investigator)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Urinary Incontinence in Children

Intervention / Treatment

  • Drug: Solifenacin
  • Drug: Mirabegron

Primary Outcome Measures

  • Treatment response (From study week 6 and through study completion, an average of 18 weeks in total)
    Assesed by change in number of wetdays pr. 7 days by DryPie

Countries

Denmark

Locations and Investigators

  • Department of Pediatric and Adolescent Medicine, Aalborg University Hospital, Aalborg, Denmark (Recruiting)
    • Søren Hagstrøm, Professor
  • Department of Pediatric and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark (Recruiting)
  • Department of Pediatric and Adolescent medicine, Esbjerg Hospital, Esbjerg, Denmark (Recruiting)
    • Linda Kuhne-Qvist, MD
  • Department of Pediatric and Adolescent Medicine, Gødstrup Hospital, Herning, Denmark (Recruiting)
    • Luise Borch, MD, PhD
    • Ann-Kristine Mandøe Svendsen, MD (Principal Investigator)
  • Department of Pediatric and Adolescent Medicine, Kolding Hospital, Kolding, Denmark (Recruiting)
    • Louise Winding, MD

Study Officials

  • Luise Borch, MD, PhD (Study Director) — Department of Pediatric and Adolescent Medicine, Gødstrup Hospital