Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe) (DEVINe Pilot)

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.

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim Pauwaert, MD; Phone Number: +32 93321182; Email: kim.pauwaert@uzgent.be
• Study Contact Backup: Name: An-Sofie Goessaert, MD, PhD; Phone Number: +32 93320247; Email: Ansofie.Goessaert@uzgent.be

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Department of Urology, Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Volunteers	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
Other: Volunteers with Venous Insuficiency	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg swelling measured in cm	Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency	25 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): May 17, 2019
• Study Completion (Actual): May 17, 2019

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Venous Insufficiency; Nocturia
• Other Study ID Numbers: UZG 2019/0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No