Randomized Controlled Trial Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- subjective cure rate of urinary incontinence at 12 months after surgery
研究概览
简要总结
Based on previous studies the single incision minisling is an easy less invasive procedure with fewer complications and cure rate similar to conventional midurethral slings in the treatment of female stress urinary incontinence. The aim of this study is to test the hypothesis that the single incision mini-sling placed in the "U" position is not inferior to TVT in this patient population.
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 (Participant, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with urodynamic stress urinary incontinence, with or without pelvic organ prolapse
排除标准
- •Patients with overactive bladder on urodynamic study.
- •Patients with voiding dysfunction.
- •Patients with intrinsic sphincteric deficiency.
- •Patients with previous anti-incontinence surgery.
- •Patients on anti-coagulant therapy.
- •Immune-compromised patients (DM, patients on corticosteroids treatment).
- •Refusal of surgery.
研究组 & 干预措施
minisling
patients in this arm will undergo single incision minisling
干预措施: single incision minisling (Procedure)
tension free vaginal tape
patients in this arm will undergo tension free vaginal tape
干预措施: tension free vaginal tape (Procedure)
结局指标
主要结局
subjective cure rate of urinary incontinence at 12 months after surgery
时间窗: 12 months
subjective cure is indicated by an Incontinence Severity Index score of 0 and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
objective cure rate of urinary incontinence at 12 months after surgery
时间窗: 12 months
Objective cure is indicated by a negative stress test and the absence of any additional surgical or nonsurgical treatment for stress urinary incontinence
次要结局
- Number of participants with long-term complications(12 months)
- Number of participants with short- term complications(12 months)
研究者
Ahmed Reda
specialist obstetrics and gynecology
Ain Shams University