Nocturia Clinical Trial
— DEVINe PilotOfficial 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.
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 |
Verified date | January 2023 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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) |
Country | Name | City | State |
---|---|---|---|
Belgium | Department of Urology, Ghent University | Gent | Oost-Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
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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