Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Edema Leg, Venous Insufficiency of Leg, Nocturia, Bio-Impedance Measurements

Intervention / Treatment
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* Behavioral: Tilt Test
* Device: Inbody S10
* Device: Tape measurements
* Device: SOMNOtouchTMNIBP, Vivisol, Belgium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteers<br> | Behavioral: Tilt Test<br>* Volunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes<br>Device: Inbody S10<br>* Bio-electrical impedance measurement every 5 minutes<br>Device: Tape measurements<br>* Every 5 minutes, circumference of every leg is measured using a tape measure<br>Device: SOMNOtouchTMNIBP, Vivisol, Belgium<br>* Continous measurement of blood pressure, heart rate and saturation<br>|
| Other: Volunteers with Venous Insuficiency<br> | Behavioral: Tilt Test<br>* Volunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes<br>Device: Inbody S10<br>* Bio-electrical impedance measurement every 5 minutes<br>Device: Tape measurements<br>* Every 5 minutes, circumference of every leg is measured using a tape measure<br>Device: SOMNOtouchTMNIBP, Vivisol, Belgium<br>* Continous measurement of blood pressure, heart rate and saturation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg swelling measured in cm | Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency | 25 minutes |