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

NCT ID: NCT06551246

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2027-12-01

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.

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).

Conditions

Urinary Incontinence in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Solifenacin

Intervention Type: DRUG

According to randomization.

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.

Group Type: EXPERIMENTAL

Solifenacin

Intervention Type: DRUG

According to randomization.

Mirabegron

Intervention Type: DRUG

According to randomization.

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.

Group Type: EXPERIMENTAL

Mirabegron

Intervention Type: DRUG

According to randomization.

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.

Group Type: EXPERIMENTAL

Solifenacin

Intervention Type: DRUG

According to randomization.

Mirabegron

Intervention Type: DRUG

According to randomization.

Interventions

Solifenacin

According to randomization.

Intervention Type: DRUG

Mirabegron

According to randomization.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luise Borch, MD, PhD

Role: STUDY_DIRECTOR

Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Locations

Department of Pediatric and Adolescent Medicine, Aalborg University Hospital

Aalborg, Aalborg, Denmark

Site Status: RECRUITING

Department of Pediatric and Adolescent Medicine, Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Site Status: RECRUITING

Department of Pediatric and Adolescent medicine, Esbjerg Hospital

Esbjerg, Esbjerg, Denmark

Site Status: RECRUITING

Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Herning, Herning, Denmark

Site Status: RECRUITING

Department of Pediatric and Adolescent Medicine, Kolding Hospital

Kolding, Kolding, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ann-Kristine Mandøe Svendsen, MD

Role: CONTACT

ankrso@rm.dk

+45 78430408

Luise Borch, MD, PhD

Role: CONTACT

luiseborch@rm.dk

+45 78433654

Facility Contacts

Søren Hagstrøm, Professor

Role: primary

soha@rm.dk

+45 97663374

Konstantinos Kamperis, MD, PhD

Role: primary

konskamp@rm.dk

Linda Kuhne-Qvist, MD

Role: primary

Linda.Kuhne-qvist2@rsyd.dk

Luise Borch, MD, PhD

Role: primary

luise.borch@rm.dk

+45 78433654

Louise Winding, MD

Role: primary

louise.winding1@rsyd.dk

References

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.

Reference Type: DERIVED

PMID: 40570329 (View on PubMed)

Other Identifiers

BeDry

Identifier Type: -

Identifier Source: org_study_id