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临床试验/NCT03388086
NCT03388086已完成不适用

Comparing the Efficacy of Two Doses of Onabotulinum Toxin for the Treatment of Neurogenic Detrusor Overactivity - a Retrospective Cohort Study

Swiss Paraplegic Research, Nottwil1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
change in detrusor pressure post-injection

研究概览

简要总结

The changes in bladder function after the injection of Onabotulinum toxin into the detrusor in individuals with neurogenic bladder overactivity will be investigated retrospectively. The records of all patients treated with Onabotulinum toxin injections into the detrusor since 2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units of Onabotulinum toxin will be compared with the changes after the injection of 200 units. Furthermore, the differences in urinary continence, duration between injections, side effects and complications between the two groups will be investigated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • neurogenic detrusor overactivity
  • spinal cord injury
  • Onabotulinum toxin injections into the detrusor from 2000-2017

排除标准

  • missing urodynamic values before or after Onabotulinum toxin injections

研究组 & 干预措施

Onabotulinum 300 units

干预措施: Injection of Onabotulinum toxin (Drug)

Onabotulinum 200 units

干预措施: Injection of Onabotulinum toxin (Drug)

结局指标

主要结局

change in detrusor pressure post-injection

时间窗: within 3 months before injection; within 2 months after injection

bladder detrusor pressure during storage phase

次要结局

  • reflexive bladder volume(within 3 months before injection; within 2 months after injection)
  • complications(within 2 months after injection)
  • maximum bladder volume(within 3 months before injection; within 2 months after injection)
  • bladder compliance(within 3 months before injection; within 2 months after injection)
  • presence of urinary incontinence(within 3 months before injection; within 2 months after injection)

研究者

发起方
Swiss Paraplegic Research, Nottwil
申办方类型
Network
责任方
Sponsor

研究点 (1)

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