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.
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
- 是
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
