Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)
- Conditions
- Venous Insufficiency of LegNocturiaBio-Impedance MeasurementsEdema Leg
- Registration Number
- NCT03928197
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Leg swelling measured in cm 25 minutes Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Urology, Ghent University
🇧🇪Gent, Oost-Vlaanderen, Belgium
Department of Urology, Ghent University🇧🇪Gent, Oost-Vlaanderen, Belgium