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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03928197
Other study ID # UZG 2019/0022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date May 17, 2019

Study information

Verified date January 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date May 17, 2019
Est. primary completion date May 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 60 Years
Eligibility 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)

Study Design


Intervention

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
Tape measurements
Every 5 minutes, circumference of every leg is measured using a tape measure
SOMNOtouchTMNIBP, Vivisol, Belgium
Continous measurement of blood pressure, heart rate and saturation

Locations

Country Name City State
Belgium Department of Urology, Ghent University Gent Oost-Vlaanderen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leg swelling measured in cm Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency 25 minutes
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