EUCTR2013-000711-24-DK进行中(未招募)1 期
The effect of combining anticholinergic treatment and transcutaneous electrical nerve stimulation in children suffering from daytime urinary incontinence and an overactive bladder.
Søren Rittig0 个研究点目标入组 90 人开始时间: 2013年9月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age 5-14 years
- •- Patients must have completed a frequency-volume chart
- •- A minimum of urinating 4 times per day according to the frequency-volume chart
- •- Daytime urinary incontinence and overactive bladder (urgency) with wetting accidents at least two days a week
- •- No effect of minimum 3 months of urotherapy including information and guidance by an urotherapist and the child must have been compliant with timed voiding.
- •- Normal clinical examination
- •- Oral and written consent from the child and parents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Neurological and/or anatomical abnormalities in the bladder and/or urinary tract system
- •- The child suffers from any type of disease that can affect the child’s ability to participate in the study or can affect the parameters that is being examined in the study
- •- Ongoing faecal problems such as constipation and/or faecal incontinence that are not well treated
- •- Former surgery in the urinary tract system
- •- Former or actual treatment with TENS and/or anticholinergics
- •- Ongoing urinary infection
- •- Treatment with any medicine that could have an effect of the parameters being examined in the study
- •- Incomplete emptying of the bladder, equal to a urinary volume of >20 ml after voiding. As examined by ultrasound
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