NCT00143481已完成4 期
A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Life and Sexual Function in Women With Overactive Bladder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.59 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2005年3月1日最近更新:
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相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 59
- 主要终点
- Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
研究概览
简要总结
The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female outpatients 18 years or older.
- •Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
- •Currently sexually active with a male partner.
排除标准
- •Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
- •Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
- •Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
- •Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)
结局指标
主要结局
Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
次要结局
- Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline
- Reasons for treatment withdrawal
- Adverse Events during the 24 week treatment period.
- Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline
- Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline
研究者
研究点 (59)
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