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临床试验/NCT03473041
NCT03473041Unknown3 期

Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence

sarah mohamed hassan1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
发起方
入组人数
140
试验地点
1
主要终点
cure rate

研究概览

简要总结

a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)

详细描述

a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling

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
25 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •stress urinary incontinence

排除标准

  • •previous surgery for stress incontinence

研究组 & 干预措施

Hybrid sling

Active Comparator

70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling

干预措施: Hybrid sling (Procedure)

TVT-O

Active Comparator

70 patients with stress urinary incontinence treated with conventional TVT-O

干预措施: TVT-O (Procedure)

结局指标

主要结局

cure rate

时间窗: 1 year follow up

negative cough stress test

次要结局

未报告次要终点

研究者

发起方
sarah mohamed hassan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

sarah mohamed hassan

lecturer of obstetrics and gynecology

Kasr El Aini Hospital

研究点 (1)

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