NCT01122563已完成不适用
Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- OABSS
研究概览
简要总结
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
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 3 urgency episode in last 3 days
- •Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- •Number of micturition ≥8 times/day
- •Number of urgency episodes in 3 days ≥3
排除标准
- •Significant stress incontinence or mixed stress/urge incontinence
- •Subject with indwelling catheters or practicing intermittent self-catheterization
- •Symptomatic urinary tract infection, chronic inflammation
- •Diabetic neuropathy
- •Subjects who are prohibited from taking solifenacin as contraindications
- •Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
- •Participation in any clinical trial in 30 days except for Part-1 of RESORT
结局指标
主要结局
OABSS
时间窗: Weeks 0, 4 and 12
次要结局
- Quality of Life (QOL) Score(Weeks 0, 4 and 12)
- Patient Perception of Bladder Condition (PPBC)(Weeks 0, 4 and 12)
- International Prostate Symptom Score (IPSS)(Weeks 0, 4 and 12)
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