IRCT20190517043609N2已完成2 期
Clinical trial of comparison of medium-term results of single incision mini-sling and stem cell therapy in the treatment of women’s stress urinary incontinence
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- Female
入选标准
- •Women at least 18 years old
- •history of SUI (Stress Urinary Incontinence)
- •Failure to respond to conservative managements after 3 months
- •Urine leak in the initial examination during coughing or Valsalva maneuver
排除标准
- •persistent urinary tract infection (UTI)
- •proved Vesicouretral Reflux (VUR)
- •History of previous Stress urinary incontinence surgery
- •history of neurological diseases such as Cerebro Vascular Accident(CVA) ,muscular dystrophy or Multiple Sclerosis(MS)
- •Obesity (Body Mass Index(BMI)> 40)
- •Localized fibrosis and stiffness at the injection site in the cystoscopy
- •high grade cystocele and rectocele (equal to or more than 3 according to the pelvic organ prolapse quantification system (POP-Q)
- •Overactive bladder symptoms (Uninhibited contractions, low capacity, low compliance in urodynamic study)
- •Medium to severe bladder trabeculation and or open bladder neck in cystourethroscopy
- •Residue of urine > 100cc and or maximum flow rates of lower than 15 ml/s
- •Pregnant or intending future pregnancies
- •coagulation disorders
- •history of Bulking agent injection in urethra
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