NCT04140253已完成不适用
A Randomized-Intervention, Parallel, Multicentric Study to Evaluate Duloxetine and Innovative Pelvic Floor Muscle Training in Women With Uncomplicated Stress Urinary Incontinence - The DULOXING Study
Comenius University2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2019年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Change in incontinence episode frequency
研究概览
简要总结
This study will evaluate the safety, tolerability and efficacy of duloxetine and pelvic floor muscle training in women who suffer from stress urinary incontinence
详细描述
This is a randomized-intervention, parallel, multicentric study which will evaluate the safety, tolerability and efficacy of oral duloxetine and innovative pelvic floor muscle training to woman suffering from 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman's willing to provide written informed consent
- •Women over 18 years that experience uncomplicated stress urinary incontinence
- •Score of the International Consultation on Urinary Incontinence Questionnaire ≥ 14 points
- •Symptoms of urinary incontinence for at least 3 consecutive months
- •Have at least seven urinary incontinence episodes per week
- •Degree of pelvic organ prolapse ≤ 2 stage
- •Willingness to accept the randomization process and fully participate in tests
排除标准
- •Recent use of any pharmacologic agent used to treat symptoms of urinary incontinence in the past six months
- •History of anti-incontinence surgery in the past 12 months
- •Use of onabotulinumtoxinA for the treatment of urinary incontinence in the past 12 months
- •History of pelvic prolapse repair or urethral surgery in the past 12 months
- •History of pelvic floor muscle training in the past 12 months
- •History of interstitial cystitis or bladder-related pain
- •Chronic severe constipation
- •Clinically significant renal or hepatic impairment
- •Clinically significant heart impairment
- •Pregnant woman, lactating, or actively trying to become pregnant
- •Non-compliance with limitation of duloxetine treatment for mixed urinary incontinence
- •Positive urinary tract infection
- •Use of rehabilitation aids (pessary, urethral plugs, vaginal beads, etc.)
- •Use of antidepressant therapy
- •Insufficient understanding of pelvic floor exercises and/or omitting exercises
- •Participation in any clinical study in the past six months
结局指标
主要结局
Change in incontinence episode frequency
时间窗: over 12 weeks of treatment
The investigators will compare change in incontinence episode frequency in the combined duloxetine and pelvic floor muscle training to duloxetine treatment alone
次要结局
- Change in Patient Global Impression of Improvement (PGI-I score)(over 12 weeks of treatment)
- Incidence of adverse events(over 12 weeks of treatment)
- Change in incontinence quality of life according to Incontinence Quality of Life scale (I-QoL)(over 12 weeks of treatment)
研究者
研究点 (2)
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