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Tests treatment safety and results for Urinary Incontinence in Children
Official title Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
ClinicalTrials.gov ID: NCT06551246
What this study is testing
What is Solifenacin?
Solifenacin is an investigational medicine, being studied as a potential treatment for urinary incontinence in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 14
You may be able to join if
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
- Age 5 to 14 years (inclusive) at the time of inclusion.
- 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)
You likely can't join 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
See the full eligibility criteria
- The participants custody holder(s) must voluntarily sign and date an informed consent prior to initiation of any study specific procedures.
- Age 5 to 14 years (inclusive) at the time of inclusion.
- 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
- 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
- Pregnancy or breastfeeding
- Female people of childbearing potential
- Ongoing constipation according to Rome IV-criteria which is intractable to medication or fecal incontinence
- Inability to swallow study medication
- Use of any medication during study period, except permitted medication
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Aalborg, Denmark
- Aarhus, Aarhus N, Denmark
- Esbjerg, Esbjerg, Denmark
- Herning, Herning, Denmark
- Kolding, Kolding, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Aalborg, Denmark; Aarhus, Aarhus N, Denmark; Esbjerg, Esbjerg, Denmark; Herning, Herning, Denmark; Kolding, Kolding, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.