EUCTR2014-004641-27-BE进行中（未招募）1 期
BOTOX in the treatment of urinary incontinence due to neurogenic detrusor overactivity in patients 3 months - 17 years - Botox treatment
ZLeuven0 个研究点目标入组 30 人开始时间: 2015年4月21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
- 30
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
- •- Male or female, = 0 and = 17 years of age at the moment of signing the informed consent
- •- Patient with neurogenic bladder dysfunction shown during urodynamic investigation with or without overactive detrusor contraction
- •- Neurogenic detrusor overactivity caused by;
- •* spinal dysrafie, more specifically spina bifida (e.g. myelomeningocele, meningocele) and all forms of tethered cord
- •* Acquired neurogenic detrusor overactivity due to spinal cord injury
- •- Regular intermittent sondage to empty the bladder
- •- more than 4 episodes of urine incontinence over two days in the miction diary
- •- the neurogenic bladder dysfunction is not sufficiently controlled with anticholinergics only
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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
- •- occurence of uncontrolled systemic diseases
- •- occurence of malignancies
- •- spinal cord surgery during the past 6 months
- •- additional pelvic or urologic abnormalities (open bladder neck, urethra stricture/urethra valve
- •- predominance of stress incontinence
研究者
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