NCT01318837已完成4 期
Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Changes from baseline to week 12 in OABSS
研究概览
简要总结
This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
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 of OAB for 3 months or longer
- •At least 1 urgency episode in last 3 days
- •Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- •a. Number of micturition ≥8 times/day
- •b. 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
- •Diabetic neuropathy
研究组 & 干预措施
sofilenacin group
Experimental
干预措施: solifenacin (Drug)
结局指标
主要结局
Changes from baseline to week 12 in OABSS
时间窗: week 0 (baseline) and week 12
Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)
时间窗: week 0 (baseline) and week 4
次要结局
- Changes from baseline in International Prostate Symptom Score (IPSS) at week 4(week 0 (baseline) and week 4)
- Changes from baseline in IPSS at week 12(week 0 (baseline) and week 12)
- Changes from baseline in Quality of Life (QoL) Score at week 4(week 0 (baseline) and week 4)
- Changes from baseline in QoL Score at week 12(week 0 (baseline) and week 12)
- Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4(week 0 (baseline) and week 4)
- Changes from baseline in PPBC at week 12(week 0 (baseline) and week 12)
研究者
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