EUCTR2021-000559-38-DK进行中（未招募）1 期
The effect of intravesical Lidocaine solution versus placebo as anesthesia prior to intravesical injection of onabotulinum toxin A. A randomized, double-blind, placebo controlled cross-over study
Herlev and Gentofte University Hospital, Department of Obstetrics and Gynecology0 个研究点目标入组 50 人开始时间: 2021年11月17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
- 50
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
- •Female, age =18 years
- •Admitted to treatment with BTX-A injections at the Urogynecological Clinic at Herlev Hospital due to UUI
- •Able to read and understand Danish
- •The female accepts to receive BTX-A injection as an outpatient treatment without the option of receiving sedative drugs
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •BTX-A allergy
- •Neurological disorder that may affect bladder function (e.g. Multiple sclerosis or spinal cord inju-ry)
- •Neurological disorder with neuromuscular transmission failure (i.e. Mystenia Gravis)
- •Positive urine culture and symptoms of urinary tract infection prior to treatment
- •Any other bladder pathology at the time of cystoscopy if identified (includes trauma, stones, tu-mor)
- •Pregnancy/breastfeeding women
研究者
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