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临床试验/NCT03928197
NCT03928197已完成不适用

Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe - Trial) - Pilootstudie: definiëren Van Duidelijke Afkapwaarden Omtrent Oedeem Ter Hoogte Van de Onderste Ledematen te Gevolge Van Veneuze insufficiëntie.

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Leg swelling measured in cm

研究概览

简要总结

Nocturia, or waking during the night to pass urine, is a multifactorial disease. An important cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs. Venous insufficiency is an important cause of peripheral edema. The investigators hypothesize that, as a result of the lying position during the night, the accumulated fluid in the lower limbs returns to the systemical circulation leading and is excreted during nighttime. This will lead to a higher voiding frequency during the night.

With this trail the investigators wanst to prove the difference in leg edema between healthy volunteers and volunteers with venous insufficiency (Type 1 or 2).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 25 years and 60 years
  • For the volunteers with venous insuffiency: clearly visual venous insufficiency (CEAP 1 and 2)
  • BMI between 24 and 30

排除标准

  • Volunteers using medication (exception for contraception)
  • Volunteers having comorbidities
  • Pregnant women
  • Women who menstruate on the test date
  • Volunteers with an implanted elektronical device (IPG, Pacemaker)

结局指标

主要结局

Leg swelling measured in cm

时间窗: 25 minutes

Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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