NCT05616481招募中不适用
Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial
适应症
干预措施
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
- 否
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.
研究组 & 干预措施
Laparoscopic Burch
Active Comparator
The original procedure will be performed
干预措施: Laparoscopic Burch colposuspension (Procedure)
Laparoscopic modefied Burch procedur (TOT-like)
Active Comparator
Sutures on the pubocervical fascia are placed at the level of the attachment of the arcus tendinous fascia pelvis and the pubourethral ligament.
干预措施: Modefied Burch (TOT - like) (Procedure)
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
- Complication rates of both techniques.(up to 3 months)
- Post operative rates of voiding dysfunction (at 3 months).(at 3 months)
- Overall operative time(Intraoperative (measured from verrus needle insertion))
研究者
Mohamed Fawzy Abd Elfattah Salman
Director
Al-Azhar University
研究点 (1)
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