NCT03928197

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

16 days

First QC Date

April 23, 2019

Last Update Submit

January 5, 2023

Conditions

Edema LegVenous Insufficiency of LegNocturiaBio-Impedance Measurements

Outcome Measures

Primary Outcomes (1)

  • Leg swelling measured in cm

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

    25 minutes

Study Arms (2)

Healthy Volunteers

OTHER
Behavioral: Tilt TestDevice: Inbody S10Device: Tape measurementsDevice: SOMNOtouchTMNIBP, Vivisol, Belgium

Volunteers with Venous Insuficiency

OTHER
Behavioral: Tilt TestDevice: Inbody S10Device: Tape measurementsDevice: SOMNOtouchTMNIBP, Vivisol, Belgium

Interventions

Tilt TestBEHAVIORAL

Volunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes

Healthy VolunteersVolunteers with Venous Insuficiency
Inbody S10DEVICE

Bio-electrical impedance measurement every 5 minutes

Healthy VolunteersVolunteers with Venous Insuficiency
Tape measurementsDEVICE

Every 5 minutes, circumference of every leg is measured using a tape measure

Healthy VolunteersVolunteers with Venous Insuficiency
SOMNOtouchTMNIBP, Vivisol, BelgiumDEVICE

Continous measurement of blood pressure, heart rate and saturation

Healthy VolunteersVolunteers with Venous Insuficiency

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 26, 2019

Study Start

May 1, 2019

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

January 9, 2023

Record last verified: 2023-01

Locations

BE(1)