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Trial record 54 of 272 for:    Recruiting, Not yet recruiting, Available Studies | "Lower Urinary Tract Symptoms"

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

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ClinicalTrials.gov Identifier: NCT03928197
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
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. We 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 we want to prove the difference in leg edema between healthy volunteers and volunteers with venous insufficiency (Type 1 or 2).


Condition or disease Intervention/treatment Phase
Edema Leg Venous Insufficiency of Leg Nocturia Bio-Impedance Measurements Behavioral: Tilt Test Device: Inbody S10 Device: Tape measurements Device: SOMNOtouchTMNIBP, Vivisol, Belgium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : May 1, 2020

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Leg swelling [ Time Frame: 25 minutes ]
    Difference in lower limb swelling between healthy volunteers and volunteers with venous insufficiency



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928197


Contacts
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Contact: Kim Pauwaert, MD +32 93321182 kim.pauwaert@uzgent.be
Contact: An-Sofie Goessaert, MD, PhD +32 93320247 ansofie.goessaert@uzgent.be

Locations
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Belgium
Department of Urology, Ghent University Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Kim Pauwaert, MD    +32 93321182    kim.pauwaert@uzgent.be   
Contact: An-Sofie Goessaert, MD, PhD    +32 93320247    Ansofie.Goessaert@uzgent.be   
Principal Investigator: Kim Pauwaert, MD         
Principal Investigator: An-Sofie Goessaert, MD, PhD         
Principal Investigator: Karel Everaert, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03928197     History of Changes
Other Study ID Numbers: UZG 2019/0022
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Venous Insufficiency
Nocturia
Vascular Diseases
Cardiovascular Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms