MedTrace Logo

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

NCT06551246 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2025-12-15

No results posted yet for this study

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

Interventions

DRUG

Solifenacin

According to randomization.

DRUG

Mirabegron

According to randomization.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Luise Borch, MD, PhD · Department of Pediatric and Adolescent Medicine, Gødstrup Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-27
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06551246 on ClinicalTrials.gov