Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)
Recruiting
Phase 3
Interventional Study
Urinary Incontinence in Children
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 5 – 14
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 236 (estimated)
- Sponsor
- University of Aarhus · Other
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About This Trial
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 responder…
Trial Locations
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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 crit…
Contacts