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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Leg swelling measured in cm
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Volunteers with Venous Insuficiency
Intervention: SOMNOtouchTMNIBP, Vivisol, Belgium (Device)
Volunteers with Venous Insuficiency
Intervention: Tape measurements (Device)
Volunteers with Venous Insuficiency
Intervention: Inbody S10 (Device)
Healthy Volunteers
Intervention: Tape measurements (Device)
Healthy Volunteers
Intervention: SOMNOtouchTMNIBP, Vivisol, Belgium (Device)
Volunteers with Venous Insuficiency
Intervention: Tilt Test (Behavioral)
Healthy Volunteers
Intervention: Inbody S10 (Device)
Healthy Volunteers
Intervention: Tilt Test (Behavioral)
Outcomes
Primary Outcomes
Leg swelling measured in cm
Time Frame: 25 minutes
Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency
Secondary Outcomes
No secondary outcomes reported