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

NCT06551246 | Recruiting Phase 3

• 1 other identifier: BeDry
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 5

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

Keywords

Urinary incontinence; Daytime urinary incontinence; Overactive bladder; Children; Solifenacin; Mirabegron

Outcome Measures

Primary Outcomes (1)

• Treatment response

  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 Outcomes (9)

• Treatment response

  From date of randomization until study completion, an average of 18 weeks in total

• Inconcintnence severity score

  From date of randomization until study completion, an average of 18 weeks in total

• Urge severity

  From date of randomization until study completion, an average of 18 weeks in total

• Maximum voided volume (ml)

  From date of randomization until study completion, an average of 18 weeks in total

• Age standardized maximum voided volume (ml)

  From date of randomization until study completion, an average of 18 weeks in total

Study Arms (4)

Solifenacin 5 mg + add-on solifenacin 5 mg

EXPERIMENTAL

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

Solifenacin 5 mg + add-on mirabegron 25 mg

EXPERIMENTAL

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; Drug: Mirabegron

Mirabegron 25 mg + ad-on mirabegron 25 mg

EXPERIMENTAL

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

Mirabegron 25 mg + add-on solifenacin 5 mg

EXPERIMENTAL

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; Drug: Mirabegron

Interventions

Solifenacin DRUG

According to randomization.

Mirabegron 25 mg + add-on solifenacin 5 mg; Solifenacin 5 mg + add-on mirabegron 25 mg; Solifenacin 5 mg + add-on solifenacin 5 mg

Mirabegron DRUG

According to randomization.

Mirabegron 25 mg + ad-on mirabegron 25 mg; Mirabegron 25 mg + add-on solifenacin 5 mg; Solifenacin 5 mg + add-on mirabegron 25 mg

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Inability of the patent(s) or legal guardian(s) to understand the Danish written and oral information
• Known or suspected hypersensitivity to study medication
• Any contraindication to the use of the study medication
• Known urogenital anatomical abnormalities affecting lower urinary tract function
• Known kidney or bladder stones
• Known diabetes insipidus
• Ongoing symptomatic urinary tract infection
• Recurrent urinary tract infection or ongoing prophylactic antibiotic treatment
• Known QTc prolongation, QTc \>460 ms, or risk of QTc prolongation (hypokalaemia, exercise-induced syncope, or familial long QT syndrome)
• Other significant electrocardiogram abnormalities
• Known hypertension
• ≤3 daily voiding, evaluated by 48-hour frequency-volume chart
• Uroflowmetry suggestive of other pathology than overactive bladder (staccato-shaped, interrupted-shaped, or plateau-shaped curve)
• Post-void residual \>50 ml after double voiding
• Dipstick haematuria (≥2+ erythrocytes) or macroscopic haematuria

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (5)

Department of Pediatric and Adolescent Medicine, Aalborg University Hospital

Aalborg, Aalborg, 9000, Denmark

RECRUITING

Department of Pediatric and Adolescent Medicine, Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Department of Pediatric and Adolescent medicine, Esbjerg Hospital

Esbjerg, Esbjerg, 6700, Denmark

RECRUITING

Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Herning, Herning, 7400, Denmark

RECRUITING

Department of Pediatric and Adolescent Medicine, Kolding Hospital

Kolding, Kolding, 6000, Denmark

RECRUITING

Related Publications (1)

• Svendsen AM, Hagstrom S, Thorsteinsson K, Van Batavia J, Kamperis K, Olesen AE, Borch L. Efficacy of Solifenacin, Mirabegron, and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry): Protocol for a Randomized Single-Blinded Controlled Trial. JMIR Res Protoc. 2025 Jun 26;14:e63588. doi: 10.2196/63588.

  PMID: 40570329 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Diurnal Enuresis; Urinary Bladder, Overactive

Interventions

Solifenacin Succinate; mirabegron

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Luise Borch, MD, PhD

  Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

  STUDY DIRECTOR

Central Study Contacts

Ann-Kristine Mandøe Svendsen, MD

CONTACT

+45 78430408; ankrso@rm.dk

Luise Borch, MD, PhD

CONTACT

+45 78433654; luiseborch@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study is single-blinded, and the study subject will receive medication delivered from the study site. The investigator does not know which treatment the individual participant receives. Participants will be informed that they are not allowed to reveal the blinded investigator the study medication, and an unblinded nurse will guide and answer questions to participants in case of dose titration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: August 13, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)