Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

Nocturia Clinical Trial

— DEVINe Pilot  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928197
• Other study ID #: UZG 2019/0022
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

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

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