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

December 5, 2025 updated by: University of Aarhus

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: According to International Children's Continence Society, 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.

Objectives: 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.

Study design: The BeDry study is designed as a multicenter, randomized, single-blinded, controlled clinical trial. Included children will be randomized 1:1:1:1 to one of four treatment groups. Children aged 5-14 years diagnosed with daytime urinary incontinence refractory to standard urotherapy will be randomized. 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.

Perspectives: 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.

Ethics: All pharmacological side effects will be handled in accordance with the Danish legislation. No risk or unknown side effects are expected to urotherapy, medical treatment or withdrawal. No risks are expected by the clinical examination and paraclinical measurements. The therapeutic potential for future patients justifies the project to be carried out. Participation in this study will not lead to any disadvantages for the patient in their treatment. The study will be conducted in accordance with the protocol, applicable regulatory requirements according to Good Clinical Practice and the ethical principles of the Declaration of Helsinki. The study is approved by the authorities. Significant additions or changes to the protocol may be conducted after the application for amendment is approved by the Regulatory Authority and the Ethics Committee. Information regarding the participants is protected according to the General Data Protection Regulation and the actual law. The study is registered at the research inventory of the Regions of Denmark (1-16-02-210-24) and at Aarhus University (ARG-2024-731-23829). The study is registered and authorized at CTIS (EU CT 2023-510187-13-00).

Study Type

Interventional

Enrollment (Estimated)

236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ann-Kristine Mandøe Svendsen, MD
  • Phone Number: +45 78430408
  • Email: ankrso@rm.dk

Study Contact Backup

Study Locations

  • Denmark
    • Aalborg
      • Aalborg, Aalborg, Denmark, 9000
        • Recruiting
        • Department of Pediatric and Adolescent Medicine, Aalborg University Hospital
        • Contact:
          • Søren Hagstrøm, Professor
          • Phone Number: +45 97663374
          • Email: soha@rm.dk
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Recruiting
        • Department of Pediatric and Adolescent Medicine, Aarhus University Hospital
        • Contact:
        • Sub-Investigator:
          • Ann-Kristine Mandøe Svendsen, MD
    • Esbjerg
      • Esbjerg, Esbjerg, Denmark, 6700
        • Recruiting
        • Department of Pediatric and Adolescent medicine, Esbjerg Hospital
        • Contact:
    • Herning
      • Herning, Herning, Denmark, 7400
        • Recruiting
        • Department of Pediatric and Adolescent Medicine, Gødstrup Hospital
        • Contact:
        • Principal Investigator:
          • Ann-Kristine Mandøe Svendsen, MD
    • Kolding
      • Kolding, Kolding, Denmark, 6000
        • Recruiting
        • Department of Pediatric and Adolescent Medicine, Kolding Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
  2. Age 5 to 14 years (inclusive) at the time of inclusion.
  3. Overactive bladder as per International Children's Continence Society criteria
  4. At least 2 daytime urinary incontinence episodes per week
  5. Inadequate effect of at least 4 weeks urotherapy (non-pharmacological treatment)
  6. No previous treatment with solifenacin, mirabegron or bladder/sphincter botulinum toxin injections
  7. No current constipation as per ROME IV criteria or fecal incontinence (laxative treatment is accepted)
  8. Per investigator's judgment, the participant can swallow or can learn to swallow study medication

Exclusion Criteria:

  1. Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information
  2. Known or suspected hypersensitivity to study medication
  3. Any contraindication to the use of the study medication
  4. Known urogenital anatomical abnormalities affecting lower urinary tract function
  5. Known kidney or bladder stones
  6. Known diabetes insipidus
  7. Ongoing symptomatic urinary tract infection
  8. Recurrent urinary tract infection or ongoing prophylactic antibiotic treatment
  9. Known QTc prolongation, QTc >460 ms, or risk of QTc prolongation (hypokalaemia, exercise-induced syncope, or familial long QT syndrome)
  10. Other significant electrocardiogram abnormalities
  11. Known hypertension
  12. ≤3 daily voiding, evaluated by 48-hour frequency-volume chart
  13. Uroflowmetry suggestive of other pathology than overactive bladder (staccato-shaped, interrupted-shaped, or plateau-shaped curve)
  14. Post-void residual >50 ml after double voiding
  15. Dipstick haematuria (≥2+ erythrocytes) or macroscopic haematuria
  16. Pregnancy or breastfeeding
  17. Female subjects of childbearing potential
  18. Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence
  19. Inability to swallow study medication
  20. Use of any medication during study period, except permitted medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solifenacin 5 mg + add-on solifenacin 5 mg
Group 1A: Solifenacin 5 mg for 6 weeks, and if non-complete response after 6 weeks add-on solifenacin 5 mg for 12 weeks.
Drug: Solifenacin
According to randomization.
Experimental: Solifenacin 5 mg + add-on mirabegron 25 mg
Group 1B: Solifenacin 5 mg for 6 weeks, and if non-complete response after 6 weeks add-on mirabegron 25 mg for 12 weeks.
Drug: Solifenacin
According to randomization.
Drug: Mirabegron
According to randomization.
Experimental: Mirabegron 25 mg + ad-on mirabegron 25 mg
Group 2A: Mirabegron 25 mg for 6 weeks, and if non-complete response after 6 weeks add-on mirabegron 25 mg for 12 weeks.
Drug: Mirabegron
According to randomization.
Experimental: Mirabegron 25 mg + add-on solifenacin 5 mg
Group 2B: Mirabegron 25 mg for 6 weeks, and if non-complete response after 6 weeks add-on solifenacin 5 mg for 12 weeks.
Drug: Solifenacin
According to randomization.
Drug: Mirabegron
According to randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response
Time Frame: 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
From study week 6 and through study completion, an average of 18 weeks in total

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
Assesed by change in number of wetdays pr. 7 days by DryPie
From date of randomization until study completion, an average of 18 weeks in total
Inconcintnence severity score
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
Assesed by DryPie (scoring from 0 to 21, in which the higher score means severe incontinence)
From date of randomization until study completion, an average of 18 weeks in total
Urge severity
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
Quantified by Bower VAS Urgency Scheme (scoring from 0 to 10, in which the higher score means servere urge)
From date of randomization until study completion, an average of 18 weeks in total
Maximum voided volume (ml)
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
48-hour frequency-volume chart
From date of randomization until study completion, an average of 18 weeks in total
Age standardized maximum voided volume (ml)
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
Maximum voided volume as a percent of expected bladder capacity
From date of randomization until study completion, an average of 18 weeks in total
Average voided volume (ml)
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
48-hour frequency-volume chart
From date of randomization until study completion, an average of 18 weeks in total
Miction frequency
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
48-hour frequency-volume chart
From date of randomization until study completion, an average of 18 weeks in total
Pediatric incontinence questionnaire total score
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
20-item questionnaire (scoring from 0 to 4 on a Likert scale, with a total of 80 points in which the higher score, the greater impact of urinary incontinence of quality of life)
From date of randomization until study completion, an average of 18 weeks in total
WHO-5 total score
Time Frame: From date of randomization until study completion, an average of 18 weeks in total
5-item questionnaire (scoring from 0 to 5 on a Likert scale, with a total of 30 points in which the higher score, the greater impact of urinary incontinence of quality of life)
From date of randomization until study completion, an average of 18 weeks in total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeDry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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