NCT01323426Unknown1 期
Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence
Copenhagen University Hospital at Herlev2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Frequency of incontinence episodes
研究概览
简要总结
This pilot study examines safety and efficacy of a simple procedure for treatment of stress urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the urethral sphincter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Stress urinary incontinence refractory to conservative treatment.
排除标准
- •urge urinary incontinence
- •Pregnancy
- •Pelvic organ prolapse > grade 1
结局指标
主要结局
Frequency of incontinence episodes
时间窗: 12 months
Reduction in the number of leakages in three days
次要结局
- International Consultation on Incontinence (ICIQ)short form incontinence score(12 months)
- Intraurethral pressure measured by reflectometry(12 months)
- Uroflow(12 months)
- Adverse events peri- or postoperatively(12 months)
研究者
研究点 (2)
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