NCT03928197: DEVINe Pilot

Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

Completed NA Last updated 9 January 2023

What this trial tests

NA trial testing Tilt Test in Edema Leg in 56 participants. Completed in 17 May 2019.

Timeline

1 May 2019

Primary endpoint
17 May 2019

17 May 2019

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	56
Start date	1 May 2019
Primary completion	17 May 2019
Estimated completion	17 May 2019
Sites	1 location across Belgium

Drugs / interventions tested

• Tilt Test
• Inbody S10
• Tape measurements
• SOMNOtouchTMNIBP, Vivisol, Belgium

Conditions studied

• Edema Leg — all drugs for Edema Leg →
• Venous Insufficiency of Leg — all drugs for Venous Insufficiency of Leg →
• Nocturia — all drugs for Nocturia →
• Bio-Impedance Measurements — all drugs for Bio-Impedance Measurements →

Sponsor

University Hospital, Ghent

Who can join

Adults 25 to 60, any sex, with Edema Leg or Venous Insufficiency of Leg. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.