Evaluation the Effect of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Stress Urinary Incontinency,The Randomized Clinical Trial Phase II
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 24hr voiding diary reduction
研究概览
简要总结
This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.
详细描述
The investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.
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
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stress Urinary Incontinence symptoms
- •Urodynamic stress incontinence confirmed with multichannel urodynamic testing
- •positive cough stress test
- •urgency score < stress score
- •Patient's age between 40 - 65 years
- •Desire to surgical correction of stress urinary incontinence or inadequate response to conservative treatment of SUI
排除标准
- •Post-void residual volume >100cc
- •Detrusor overactivity on preoperative multichannel urodynamic testing
- •History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra
- •Desires future childbearing
- •Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurative
- •History of bleeding diathesis or current anti-coagulation therapy
- •Inguinal lymphadenopathy or inguinal/vulvar mass
- •Current genitourinary fistula or urethral diverticulum
- •Current sever cystocele or rectocele
- •Active urinary infection
- •Non-treated urge incontinency or any significant voiding dysfunction
- •Neuromuscular disorders
- •Uncontrolled Diabetes
- •Reversible cause of incontinence (i.e. drug effect)
- •Contraindications for surgery
结局指标
主要结局
24hr voiding diary reduction
时间窗: 1 month
Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.
次要结局
- incontinence quality of life (I-Qol)(1month)