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临床试验/NCT05616481
NCT05616481招募中不适用

Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence

研究概览

简要总结

This study aims to compare the success rate and complications following laparoscopic standard Burch colposuspension and laparoscopic modified Burch colposuspension (Transobturator tape like)

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
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

入选标准

  • Women with genuine stress urinary incontinence.
  • Mixed urinary incontinence with predominant stress element.
  • Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment.

排除标准

  • Mixed incontinence with predominant Urge urinary incontinence.
  • Recent pelvic surgery (less than 3 months).
  • Neurogenic lower urinary tract dysfunction.
  • Previous surgery for stress urinary incontinence.
  • Pregnancy
  • Less than 12 months post-partum.
  • Other gynaecologic pathologies affecting bladder functions ( eg, fibroids, ovarian cysts)
  • Genito-urinary malignancy.
  • Current chemo or radiation therapy.

结局指标

主要结局

The success rates of both laparoscopic Burch colposuspension versus laparoscopic modified Burch colposuspension for treatment of female stress urinary incontinence

时间窗: 3 months post operative

次要结局

  • Post operative rates of voiding dysfunction (at 3 months).(at 3 months)
  • Complication rates of both techniques.(up to 3 months)
  • Overall operative time(Intraoperative (measured from verrus needle insertion))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Fawzy Abd Elfattah Salman

Director

Al-Azhar University

研究点 (1)

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