BeDry

Phase 1

Recruiting

Conditions: Daytime urinary incontinence and overactive bladder
MedDRA version: 21.1Level: LLTClassification code: 10021642Term: Incontinence of urine Class: 10038359
MedDRA version: 20.0Level: LLTClassification code: 10008523Term: Childhood incontinence Class: 10038359
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

Registration Number: CTIS2023-510187-13-00

Lead Sponsor: Region Midtjylland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 236

Inclusion Criteria

1.The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation any study specific procedures., Age 5 to 14 years (inclusive) at the time of signing the consent., Overactive bladder as per ICCS criteria, At least 2 daytime urinary incontinens episodes per week, Inadequate effect of 4 weeks urotherapy (non-pharmacological treatment), No previous treatment with solifenacin, mirabegron, intradetrusor 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

Exclusion Criteria

Inability of the patent(s) or parental custody holder(s) to understand the Danish written and oral information, Inability to swallow study medication, 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 (central or nephrogenic), Ongoing symptomatic urinary tract infection (dysuria, fever, bacterial growth by urine culturing), 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), Female subjects of childbearing potential, Other significant ECG abnormalities, Known hypertension, =3 daily voiding, evaluated by 48-hour frequency-volume chart, Uroflowmetry suggestive of other pathology than OAB (staccato-shaped, interrupted-shaped, or plateau-shaped curve), Post-void residual >50 ml after doublet voiding, Dipstick haematuria (=2+ erythrocytes) or macroscopic haematuria, Pregnancy or breastfeeding, Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the effect of solifenacin versus mirabegron versus combination therapy of solifenacin and mirabegron, in treatment of daytime urinary incontinence in children aged 5 to 14 years.;Secondary Objective: The secondary objective is to evaluate side effects, safety, and tolerability of solifenacin, mirabegron and combination therapy, as well as the effect of treatment on well-being and quality of life.;Primary end point(s): The primary outcome measure is treatment response as defined by non-response (<50% decrease in number of wet days) and response (50-100% decrease in number of wet days), assessed by a change from visit 2 and across the 12-week pharmacological treatment period. The number of wet days is assessed pr. 7 days by DryPie. The treatment response will be evaluated for solifenacin, mirabegron and combination of solifenacin and mirabegron.

Secondary Outcome Measures