NCT01122550已完成不适用
Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 1: Reproducibility -
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
- 否
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
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