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Completed

NCT Number: NCT03928197

Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

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).

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Key information

Conditions

Edema Leg Bio-Impedance Measurements Lower Urinary Tract Symptoms Nocturia Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations Venous Insufficiency of Leg

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tilt Test

Behavioral

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

InBody S10

Device

Bio-electrical impedance measurement every 5 minutes

Tape measurements

Device

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

SOMNOtouchTMNIBP, Vivisol, Belgium

Device

Continous measurement of blood pressure, heart rate and saturation

Primary outcomes

  1. Leg swelling measured in cm

    Time frame: 25 minutes

    Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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.

Acronym: DEVINe Pilot

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2019
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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