NCT00190606已完成2 期
Efficacy and Safety of Duloxetine Compared With Placebo,Pelvic Floor Muscle Training, and Combined Duloxetine/Pelvic Floor Muscle Training in Subjects With Moderate to Sever Stress Urinary Incontinence
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Effectiveness of combined duloxetine and PFMT with combined placebo and imitation PFMT in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint.
研究概览
简要总结
The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 75 years of age
- •Confirmed pure genuine stress incontinence
- •Have discrete episodes of incontinence
- •Have pelvic organ prolapse of no greater than Stage II
排除标准
- •Positive urine culture at visit 1
- •Had formal PFMT with instruction
- •Use of MAOI or other excluded medications
- •Use of any anti-incontinence device, vaginal pessaries or any medication prescribed for the treatment of urinary incontinence
结局指标
主要结局
Effectiveness of combined duloxetine and PFMT with combined placebo and imitation PFMT in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint.
Effectiveness of combined duloxetine and PFMT with combined placebo and PFMT for up to 12 weeks in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint.
次要结局
- Incontinence Quality of Life scores from baseline to endpoint.
- Symptoms Frequency & Bothersomeness.
- Patient Global Impression - Impression at endpoint.
- Percent change in weekly continence pad usage (CPAD) from baseline to endpoint.
- Change in Patient Satisfaction Questionnaires -2 and -4 questionnaire scores from baseline to endpoint.
- Percent change in daily CPAD from baseline to endpoint.
- Compare safety of duloxetine with placebo based on vital signs , laboratory values and the occurrence of treatment-emergent adverse events.
- Compare combined duloxetine and PFMT, combined duloxetine and imitation PFMT, combined placebo with PFMT and combined placebo and imitation PFMTwith respect to efficacy and to safety.
- Compare the effect of duloxetine and placebo on patient compliance to PFMT and imitation PFMT regimes using a daly patient-generated log of completed contractions.
- Generate long-term safety data (during open-label extension) on duloxetine in the treatment of women with SUI.
研究者
研究点 (3)
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