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

Primary Purpose

Edema Leg, Venous Insufficiency of Leg, Nocturia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Tilt Test
Inbody S10
Tape measurements
SOMNOtouchTMNIBP, Vivisol, Belgium
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Edema Leg

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of Urology, Ghent University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Healthy Volunteers

Volunteers with Venous Insuficiency

Arm Description

Outcomes

Primary Outcome Measures

Leg swelling measured in cm
Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency

Secondary Outcome Measures

Full Information

First Posted
April 23, 2019
Last Updated
January 5, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03928197
Brief Title
Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema Leg, Venous Insufficiency of Leg, Nocturia, Bio-Impedance Measurements

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Other
Arm Title
Volunteers with Venous Insuficiency
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Tilt Test
Intervention Description
Volunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes
Intervention Type
Device
Intervention Name(s)
Inbody S10
Intervention Description
Bio-electrical impedance measurement every 5 minutes
Intervention Type
Device
Intervention Name(s)
Tape measurements
Intervention Description
Every 5 minutes, circumference of every leg is measured using a tape measure
Intervention Type
Device
Intervention Name(s)
SOMNOtouchTMNIBP, Vivisol, Belgium
Intervention Description
Continous measurement of blood pressure, heart rate and saturation
Primary Outcome Measure Information:
Title
Leg swelling measured in cm
Description
Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency
Time Frame
25 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Department of Urology, Ghent University
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

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