A Two Paramedian Vaginal Incisions Versus the Standard Longitudinal Incision of Trans-Obturator Tape Procedure for Management of Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- tape migration
研究概览
简要总结
In trans-obturator tape (TOT), tension and location of the tape in mid urethral zone are directly related to the postoperative clinical outcome. Recurrence of symptoms of stress urinary incontinence has been related to tape migration in previous studies. The study aimed to increase the success rate of TOT procedure through a new surgical technique using a 2 paramedian vaginal incisions.
详细描述
the investigator innovated a new technique that involves a 2 paramedian vaginal incisions that allow more tape stabilization with sparing the dissection along the whole urethra ensuring intact overlying tissues and to create a tunnel in between the 2 incisions to pass the tape, making it supported proximally and distally with normal undissected tissues.
the study aims to assess the success rate of TOT and tape migration using a new surgical technique versus the standard procedure using vertical incision.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be blinded to the type of intervention as well as the data collector and the statistician
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult female patient complaining of pure stress incontinence confirmed by stress test of urodynamic study
排除标准
- •Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.
结局指标
主要结局
tape migration
时间窗: to be evaluated at12th month postoperative
to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
次要结局
- continence after surgery(to be evaluated at 3,6 and 12 month postoperative)
- urine retention(to be evaluated in the first 24 hours postoperative)
- de-novo urgency(to be evaluated at 12 month postoperative)
- vaginal erosion(to be evaluated up to 1 year post operative)
研究者
Ahmed Maher Gamil Ahmed Higazy
assistant lecturer of Urology
Ain Shams University