Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

Not Applicable

Completed

• Conditions: Venous Insufficiency of Leg; Nocturia; Bio-Impedance Measurements; Edema Leg
• Interventions: Behavioral: Tilt Test; Device: Inbody S10; Device: Tape measurements; Device: SOMNOtouchTMNIBP, Vivisol, Belgium

• Registration Number: NCT03928197
• Lead Sponsor: University Hospital, Ghent

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-26
• Study Start: 2019-05-01
• Primary Completion: 2019-05-17
• Study Completion: 2019-05-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Tilt Test	-
Healthy Volunteers	Tape measurements	-
Volunteers with Venous Insuficiency	Tilt Test	-
Healthy Volunteers	Inbody S10	-
Healthy Volunteers	SOMNOtouchTMNIBP, Vivisol, Belgium	-
Volunteers with Venous Insuficiency	Inbody S10	-
Volunteers with Venous Insuficiency	Tape measurements	-
Volunteers with Venous Insuficiency	SOMNOtouchTMNIBP, Vivisol, Belgium	-

Primary Outcome Measures

Name	Time	Method
Leg swelling measured in cm	25 minutes	Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency

Trial Locations

Locations (1)

Department of Urology, Ghent University; 🇧🇪 Gent, Oost-Vlaanderen, Belgium