JPRN-jRCT2080225307已完成2 期
A phase 2, randomized, placebo-controlled, double-blind study of TAS-303 in female patients with stress urinary incontinence
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- Female
入选标准
- •Key Inclusion Criteria:
- •-Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
- •-Urinary incontinence in the 1-hour pad weight test exceeds 2.0 g
- •-The average number of SUI episodes is 1 or more per day
- •- The average number of urge urinary incontinence (UUI) episodes is 0.43 or less per day
- •-The number of SUI episodes exceeds the number of other episodes
- •-The average number of urinary diurnal frequency is 10 or less per day and the average number of nocturia frequency is 2 or less per day
排除标准
- •Key Exclusion Criteria:
- •- Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI
- •- Patient has treated medication or therapy for SUI within 14 days before prior to study entry
- •- Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy
- •- Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.)
- •- Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery within 180 days before prior to study entry
- •- Patient has a serious illness or medical condition
研究者
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