跳至主要内容
临床试验/NCT02557971
NCT02557971已完成不适用

Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder

Allergan7 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2015年8月最近更新:
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
Allergan
入组人数
315
试验地点
7
主要终点
Length of Time of Clean Intermittent Catheterization (CIC) Use

研究概览

简要总结

This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients treated with BOTOX® for Overactive Bladder.

排除标准

  • Received botulinum toxin formulations other than BOTOX® in the bladder.
  • Had symptoms of OAB associated with a neurological condition.
  • Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.

研究组 & 干预措施

BOTOX®

Patients with idiopathic overactive bladder (OAB) treated with onabotulinumtoxinA (BOTOX®) injections into the bladder as standard of care in clinical practice. No intervention was administered in this study.

干预措施: onabotulinumtoxinA (Drug)

结局指标

主要结局

Length of Time of Clean Intermittent Catheterization (CIC) Use

时间窗: 12 Weeks

Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization

时间窗: 12 Weeks

次要结局

  • Percentage of Participants with Urinary Tract Infection (UTI)(12 Weeks)

研究者

发起方
Allergan
申办方类型
Industry
责任方
Sponsor

研究点 (7)

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