Efficacy of solifenacin, mirabegron and combination therapy in children with overactive bladder and daytime urinary incontinence (BeDry) - BeDry-2023

Region Midtjylland0 个研究点目标入组 236 人开始时间: 2024年1月11日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

发起方

Region Midtjylland