EUCTR2005-004716-75-GB进行中（未招募）1 期
A double blind, randomised, placebo controlled crossover study of intra-trigonal injections of Botulinum toxin type B for treating patients with idiopathic detrusor overactivity refractory to other conservative treatments. - Neurobloc crossover
Swansea NHS Trust0 个研究点目标入组 20 人开始时间: 2005年12月23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
- 20
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
入选标准
- •Patients with urodynamically proven detrusor overactivity of idiopathic aetiology.
- •Previous failed treatment with anticholinergic therapy or if anticholinergic therapy was contra-indicated.
- •Patient might otherwise be considered for neuromodulation or for augmentation or diversion surgery.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients < 18 years of age
- •Patients with proven bladder outflow obstruction
- •Any patient with neurological disease that may affect bladder function.
- •Any patients with generalised disorder of muscle activity
- •Serious concomitant illness
- •Patients with bleeding disorders
- •Pregnant or breast feeding patients
- •Patients who are unable to perform intermittent self-catheterisation
- •Patients in whom stress incontinence is the primary symptom
- •Acute urinary infection
- •Any other bladder pathology at the time of cystoscopy (includes trauma, stones, tumour)
- •Vesicoureteric reflux demonstrated on VCMG
- •Previous botulinum toxin B injections to the bladder
研究者
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