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临床试验/NCT03042351
NCT03042351已完成不适用

Pilot Study for the Urinary Incontinence Treatment by Using a Pelvic Floor Muscles Restorative Device (E-NNA®)

Instituto Palacios2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Changes in values registered in Magic Kegel App

研究概览

简要总结

Non invasive study to improve the urinary incontinence, through pelvic floor muscles exercises

详细描述

A non invasive study to improve the urinary incontinence performed in 36 women from two groups: 18 menopausal women and 18 fertile women. The participants have to do pelvic floor muscles exercises with a restorative pelvic floor device every day for two months using the Magic Kegel app download in their mobile devices

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Urinary incontinence diagnosis

排除标准

  • No urinary infection
  • No surgery for urinary incontinence

结局指标

主要结局

Changes in values registered in Magic Kegel App

时间窗: Six months

次要结局

  • Changes in ICIQ-SF questionnaire at month 2 respect to baseline(60 days)
  • Changes in Sandvick questionnaire at month 2 respect to baseline(60 days)
  • Changes in FSFI questionnaire at month 2 respect to baseline(60 days)
  • Changes in PISQ-12 questionnaire at month 2 respect to baseline(60 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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