2023-510187-13-00招募中3 期
Efficacy of solifenacin, mirabegron and combination therapy in children with overactive bladder and daytime urinary incontinence (BeDry)
Region Midtjylland4 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2024年4月19日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 236
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
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.
次要结局
- Identifications of ECG abnormalities by electrocardiogram
- Change in number of wet days pr. 7 days assessed by Dry Pie, baseline to 18 weeks
- Change in incontinence severity score pr. 7 days assessed by Dry Pie, baseline to 18 weeks
- Change in urge severity quantified by Bower VAS Urgency, baseline to 18 weeks
- Change in maximum volume voided (MVV), baseline to 18 weeks
- Change in age standardized MVV (MVV as a percent of expected bladder capacity (EBC)), baseline to 18 weeks
- Change in average voided volume (AVV), baseline to 18 weeks
- Change in micturition frequency, baseline to 18 weeks
- Change in fluid-intake, baseline to 18 weeks
- Change in maximum flow rate (Qmax) assessed by uroflowmetry, baseline to 18 weeks
- Change in Pediatric incontinence questionnaire total score, baseline to 18 weeks
- Change in WHO-5 total score, baseline to 18 weeks
- Adverse event (AE), serious adverse event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) monitoring
- Change in blood pressure and pulse, baseline to 18 weeks
- Change in ultrasonic assessed post-void residual urine, baseline to 18 weeks
- Identification of urinary tract infection by urine dipstick and verified by routine urine cultivation
- Treatment response of solifenacin, mirabegron and combination of solifenacin and mirabegron, baseline across 18 week treatment period
研究者
Ann-Kristine Mandøe Svendsen
Scientific
Region Midtjylland
研究点 (4)
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