跳至主要内容
临床试验/NCT04479709
NCT04479709已完成不适用

The Urinary Microbiome Before and After Treatment With Intradetrusor Onabotulinum Toxin A Injection for Overactive Bladder

MetroHealth Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Urinary Microbiome

研究概览

简要总结

An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB) patients who were previously considered to have "idiopathic" OAB. To date, most research on the relationship between OAB and the UM has focused on differentiating between the UM of a normal bladder and that of an OAB bladder. There is currently a paucity of data on the way that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB treatment focused on how management with solifenacin affected the UM, but no studies have evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding IOI's impact on the UM is particularly interesting because despite both anticholinergics and IOI exerting antimuscarinic affects on the bladder, IOI is often successful when anticholinergics are not. This raises the question of what other mechanisms of action IOI may have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in those select patients who suffer from OAB due to an altered UM. The primary objective of this study is therefore to determine the UM profiles of OAB patients before and after treatment with IOI.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing intradetrusor botox injection with botox 100 U

排除标准

  • Current UTI
  • History of recurrent UTI
  • History of antibiotic exposure for any reason (including if response is "unknown")
  • Antibiotic exposure for any reason other than post-procedure prophylaxis during the four-week follow-up period.

结局指标

主要结局

Urinary Microbiome

时间窗: 08/2020 - 08/2021

To evaluate whether administration of intradetrusor botox injections for the treatment of overactive bladder results in changes to the urinary microbiome.

次要结局

  • Adverse events(08/2020 - 08/2021)
  • Urinary tract infection(08/2020 - 08/2021)
  • Urinary Microbiome by response(08/2020 - 08/2021)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Mangel

Associate Professor, Case Western Reserve University School of Medicine

MetroHealth Medical Center

研究点 (1)

Loading locations...

相似试验