Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe) (DEVINe Pilot)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Venous Insufficiency of Leg; Nocturia; Edema Leg; Bio-Impedance Measurements

Treatments: Behavioral: Tilt Test; Device: SOMNOtouchTMNIBP, Vivisol, Belgium; Device: Inbody S10; Device: Tape measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT03928197

UZG 2019/0022

Details and patient eligibility

About

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).

Enrollment: 56 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Healthy Volunteers

Other group

Treatment:

Device: SOMNOtouchTMNIBP, Vivisol, Belgium

Behavioral: Tilt Test

Device: Inbody S10

Device: Tape measurements

Volunteers with Venous Insuficiency

Other group

Treatment:

Device: SOMNOtouchTMNIBP, Vivisol, Belgium

Behavioral: Tilt Test

Device: Inbody S10

Device: Tape measurements