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临床试验/NCT03300973
NCT03300973Unknown2 期

Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2016年1月15日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
125
试验地点
2
主要终点
cure of stress incontinence

研究概览

简要总结

A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

详细描述

group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • stress urinary incontinence

排除标准

  • mixed incontinence
  • recurrent cases

研究组 & 干预措施

urodynamics study group

Active Comparator

65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery

干预措施: sling surgery (Procedure)

surgery only group

Active Comparator

60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study

干预措施: sling surgery (Procedure)

结局指标

主要结局

cure of stress incontinence

时间窗: 1 week after surgery

by clinical assessment

次要结局

  • cure of stress incontinence(3 months after surgery)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

sarah mohamed hassan

lecturer of obstetrics and gynecology Cairo university

Kasr El Aini Hospital

研究点 (2)

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