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Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

NCT03928197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-01-09

No results posted yet for this study

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).

Conditions

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

Interventions

BEHAVIORAL

Tilt Test

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

DEVICE

Inbody S10

Bio-electrical impedance measurement every 5 minutes

DEVICE

Tape measurements

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

DEVICE

SOMNOtouchTMNIBP, Vivisol, Belgium

Continous measurement of blood pressure, heart rate and saturation

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-05-17
Completion
2019-05-17

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928197 on ClinicalTrials.gov