EUCTR2004-002981-39-GB进行中（未招募）1 期
Randomised trial of detrusor botulinum toxin injection (BOTOX®) compared to placebo in women with idiopathic detrusor overactivity
niversity Hospitals of Leicester NHS Trust0 个研究点目标入组 240 人开始时间: 2005年2月15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
- 240
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
- Female
入选标准
- •Age over 18
- •Women with urodynamically proven detrusor overactivity unresponsive to oral medication defined as:
- •8 weeks of continued treatment with any licensed anticholinergic drug, with a screening Patient Global Impression of Improvement (PGI-I) scale score of a little better” or worse.
- •8 weeks of continued treatment, with a verbal response that the treatment has not provided acceptable improvement
- •Treatment stopped because of side effects within 8 weeks
- •Previous treatments stopped because of lack of efficacy, and currently receiving no treatment
- •·At least 8 voids per 24 hours
- •·At least 2 urgency episodes per 24 hours
- •·Patients who have given fully informed written consent
- •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 with known multiple sclerosis, stroke, spinal injury, or other neurological disease
- •Patients with pre-existing voiding dysfunction (flow rate less than 5th centile, or post void residual volume greater than 100ml)
- •Patients fulfilling the exclusion criteria for the licensed indications of botulinum toxin (myasthenia gravis and Eaton Lambert syndrome, or allergy to constituents of BOTOX® injection)
- •Patients with co-existing urodynamic stress incontinence
研究者
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