NCT02667470已完成4 期
Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in OABSS scores from prior to treatment and after treatment
研究概览
简要总结
The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •At screening visit (Week -2):
- •Symptoms of OAB ≥ 3 months
- •Number of urgency episodes in last 3 days ≥ 3
- •Based on the 3-day micturition diary prior to Visit 1 (Week 0):
- •Number of micturition per day ≥ 8
- •Number of urgency episodes in 3 days ≥ 3
排除标准
- •At screening visit (Week -2):
- •Stress is the predominant factor as determined by the investigator
- •Indwelling catheters or practicing intermittent self-catheterization
- •Symptomatic urinary tract infection, chronic inflammation
- •Treatment for OAB was started, quitted or changed in 4 weeks
- •Diabetic neuropathy
- •At Visit 1 (Week 0):
- •Patient who did not complete the 3-day micturition diary according to the instruction
研究组 & 干预措施
Solifenacin
Experimental
干预措施: Solifenacin (Drug)
结局指标
主要结局
Change in OABSS scores from prior to treatment and after treatment
时间窗: Prior to treatment and after treatment (up to 12 weeks)
次要结局
- Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score(Prior to treatment and after treatment (up to 12 weeks))
- Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score(Prior to treatment and after treatment (up to 12 weeks))
- Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score(Prior to treatment and after treatment (up to 12 weeks))
- Correlation of change between OABSS scores and number of micturitions per day(Prior to treatment and after treatment (up to 12 weeks))
- Correlation of change between OABSS scores and number of nocturia episodes per day(Prior to treatment and after treatment (up to 12 weeks))
- Correlation of change between OABSS scores and number of total voided volume per day(Prior to treatment and after treatment (up to 12 weeks))
- Correlation of change between OABSS scores and number of incontinence episodes per day(Prior to treatment and after treatment (up to 12 weeks))
- Correlation of change between OABSS scores and number of urgency episodes per day(Prior to treatment and after treatment (up to 12 weeks))
- Correlation of change between OABSS scores and number of pads per day(Prior to treatment and after treatment (up to 12 weeks))
研究者
研究点 (1)
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