Skip to content

Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03928197
Acronym
DEVINe Pilot
Enrollment
56
Registered
2019-04-26
Start date
2019-05-01
Completion date
2019-05-17
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

BEHAVIORALTilt Test

Volunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes

Bio-electrical impedance measurement every 5 minutes

DEVICETape measurements

Every 5 minutes, circumference of every leg is measured using a tape measure

DEVICESOMNOtouchTMNIBP, Vivisol, Belgium

Continous measurement of blood pressure, heart rate and saturation

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Leg swelling measured in cm25 minutesDifference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026