NCT03928197

Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-05-17
• Completion: 2019-05-17
• First posted: 2019-04-26
• Last updated: 2023-01-09

Locations

1 site across 1 country: Belgium