BridgeMD
BeDry
EU CTIS ID: 2023-510187-13-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.