NCT00190567已完成2 期
Biomechanical Effects of Duloxetine on Bladder Function and Sphincter Resistance During the Emptying Phase and on Urethral Function During the Filling Phase of the Micturition Cycle in Women With Pure Genuine Stress 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
- 50
- 试验地点
- 2
- 主要终点
- Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure
研究概览
简要总结
Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress 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
- •Diagnosis of GSI
- •Have discrete episodes of incontinence
排除标准
- •Positive urine culture at visit 1
- •Use of MAOI
- •Have had continence or urethral surgery
- •Use of anti-incontinence device, vaginal pessaries or medications for the treatment of urinary incontinence
- •Began pelvic floor muscle exercises within 6 months prior to study entry.
结局指标
主要结局
Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure
次要结局
- Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from
- non-instrumented and instrumented uroflowmetry studies
- Percent change in Incontinent Episode Frequency (IEF) from baseline to endpoint
- Subject-perceived improvement in their GSI as measured by the Patient Global Impressions-Improvement (PGI-I) questionnaire at endpoint
- Compare duloxetine responders with duloxetine non-responders with respect to:
- Baseline measures of urethral function
- Outcome measures of urethral function
- Outcome measures of emptying function
- Vital signs, laboratory values and the occurrence of treatment-emergent adverse events
- In the open-label extension:
- Determine the effects of duloxetine six to seven months after initiation on measures of urethral function
- Collect long-term data on the maintenance of effect of duloxetine in the treatment of GSI as measured by IEF, PGI-I, vital signs, laboratory values and the occurrence of treatment-emergent adverse events.
研究者
研究点 (2)
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