跳至主要内容
临床试验/NCT01122550
NCT01122550已完成不适用

Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 1: Reproducibility -

Astellas Pharma Inc0 个研究点目标入组 50 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
OABSS

研究概览

简要总结

The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Symptoms OAB for 3 months or longer
  • At least 1 urgency episode in last 3 days
  • Symptoms of OAB as verified by 3-day micturition diary prior to Visit 1, defined by:
  • Number of micturition per day ≥8
  • Number of urgency episodes in 3 days ≥1

排除标准

  • Significant stress incontinence or mixed stress/urge incontinence
  • Subjects with indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy
  • Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
  • Participation in any clinical trial in 30 days

结局指标

主要结局

OABSS

时间窗: Weeks 0 and 2

次要结局

  • International Prostate Symptom Score (IPSS)(Weeks 0 and 2)
  • Quality of Life (QOL) score(Weeks 0 and 2)
  • Patient Perception of Bladder Condition (PPBC)(Weeks 0 and 2)

研究者

申办方类型
Industry

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