Actively Recruiting

Phase 3
Age: 5Years - 14Years
All Genders
ID06551246

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

Led by University of Aarhus · Updated on 2026-06-08

236

Participants Needed

5

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the treatment of daytime urinary incontinence in children aged 5 to 14 years who do not fully respond to low doses of either solifenacin or mirabegron alone. The goal is to see if combining low doses of both medications works better than using a high dose of either drug by itself. This is a phase 3 clinical trial designed as a multicenter, randomized, single-blinded study involving 236 children diagnosed with this condition. Participants are randomly assigned to one of four groups. Two groups start with solifenacin 5 mg daily and two groups start with mirabegron 25 mg daily for the first 6 weeks. If children do not respond completely after 6 weeks, they receive an add-on treatment for 12 more weeks: either an additional dose of the same drug or the other drug, depending on their initial group. The total treatment period lasts 18 weeks. During the study, researchers assess treatment response by tracking the number of wet days per week from week 6 through the end of the study. Additional evaluations include measuring incontinence severity, urge severity, urine volume, frequency of urination, and quality of life using questionnaires. Safety, side effects, and tolerability are also monitored. Participation involves regular visits and assessments over the full 18-week treatment period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Custody holder(s) voluntarily sign informed consent before any study procedures
  • Age between 5 to 14 years at inclusion
  • Diagnosed with overactive bladder according to International Children's Continence Society criteria
  • At least 2 daytime urinary incontinence episodes per week
  • Inadequate effect after at least 4 weeks of standard urotherapy
  • No previous treatment with solifenacin, mirabegron, or bladder/sphincter botulinum toxin injections
  • No current constipation by Rome IV criteria or fecal incontinence (laxative treatment allowed)
  • Ability to swallow or learn to swallow study medication as judged by investigator
Not Eligible

You will not qualify if you...

  • Inability of patient or legal guardian to understand Danish written and oral information
  • Known or suspected allergy to study medications
  • Any contraindication to use of study medications
  • Known urogenital anatomical abnormalities affecting lower urinary tract
  • Known kidney or bladder stones
  • Known diabetes insipidus
  • Ongoing symptomatic urinary tract infection
  • Recurrent urinary tract infection or current prophylactic antibiotic use
  • Known or risk of QTc prolongation or other significant ECG abnormalities
  • Known hypertension
  • Less than 3 daily voidings as per 48-hour frequency-volume chart
  • Uroflowmetry showing abnormal patterns other than overactive bladder
  • Post-void residual urine volume over 50 ml after double voiding
  • Dipstick haematuria or visible blood in urine
  • Pregnancy or breastfeeding
  • Female subjects of childbearing potential
  • Intractable constipation or fecal incontinence despite medication
  • Inability to swallow study medication
  • Use of any medication during study except permitted drugs

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 18 weeks

Participants receive medication treatment with solifenacin or mirabegron according to randomization. After 6 weeks, non-complete responders may receive add-on treatment based on their initial group assignment.

Visits at baseline and periodically during the 18-week treatment period

Trial Site Locations

Total: 5 locations

1

Department of Pediatric and Adolescent Medicine, Aalborg University Hospital

Aalborg, Aalborg, Denmark, 9000

Actively Recruiting

2

Department of Pediatric and Adolescent Medicine, Aarhus University Hospital

Aarhus, Aarhus N, Denmark, 8200

Actively Recruiting

3

Department of Pediatric and Adolescent medicine, Esbjerg Hospital

Esbjerg, Esbjerg, Denmark, 6700

Actively Recruiting

4

Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Herning, Herning, Denmark, 7400

Actively Recruiting

5

Department of Pediatric and Adolescent Medicine, Kolding Hospital

Kolding, Kolding, Denmark, 6000

Actively Recruiting

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Research Team

A

Ann-Kristine Mandøe Svendsen, MD

L

Luise Borch, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Frequently Asked Questions

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Published Research Related To This Trial

Efficacy of Solifenacin, Mirabegron, and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry): Protocol for a Randomized Single-Blinded Controlled Trial.

Ann-Kristine Mandøe Svendsen, Søren Hagstrøm, Kristina Thorsteinsson...

https://pubmed.ncbi.nlm.nih.gov/40570329