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Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

Primary Purpose

Nocturia, Venous Insufficiency of Leg, Fluid Overload

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Questionnaires
Frequency Volume Chart
Collect urine during 1 day
Blood sample
Measurement of the circumference of the lower legs
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nocturia

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CEAP 2 till 4A

Exclusion Criteria:

  • BMI higher than 30
  • Previous surgery due to venous insufficiency at the lower limbs
  • Cronic edema (Cronic heart failure, liver cirrosis, nefrotic syndrome)
  • Pregnant patient
  • Patients on the following medication: Calcium-antagonists, lithium, NSAID's or corticosteroids, glitazones, insuline, diuretics, sartans, ACE-inhibitors, desmopressine,

Sites / Locations

  • Department of urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

<2 nocturnal voids

=> 2 nocturnal voids

Arm Description

All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention Complete a 3 day Frequency Volume chart Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2

All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention Complete a 3 day Frequency Volume chart and collection of the urine of the last day and night to complete osmolality and sodium testing. Measuring the circumference off the lower limbs just after awakining and before falling asleep Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2

Outcomes

Primary Outcome Measures

Change of micturition frequency
Change of the micturition frequency with 1 void

Secondary Outcome Measures

Change in nocturnal diuresis

Full Information

First Posted
February 10, 2020
Last Updated
July 14, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04266496
Brief Title
Discovering the Effect of Venous Insufficiency on Nocturia
Acronym
DEVINe
Official Title
Discovering the Effect of Venous Insufficiency on Nocturia: a Prospective, Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (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
With this prospective controlled trial, we hope to obtain more information about the coexistence between venous insufficiency and nocturia. In our opinion, venous insufficiency (CEAP 2-3a) leads to an increase in fluid accumulation in the lower limbs due to moving around all day. When laying down during nighttime, this fluid is reabsorbed into the systimic fluid pool, leading to an increase in diuresis and thus an increase in nocturnal voiding. Aim of this study is observe difference in nocturnal frequency and urine production before and after surgical treatment of venous insufficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia, Venous Insufficiency of Leg, Fluid Overload

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
<2 nocturnal voids
Arm Type
Other
Arm Description
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention Complete a 3 day Frequency Volume chart Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
Arm Title
=> 2 nocturnal voids
Arm Type
Other
Arm Description
All interventions in this group are done twice: Once before surgical intervention, and once 2 months after surgical intervention Complete a 3 day Frequency Volume chart and collection of the urine of the last day and night to complete osmolality and sodium testing. Measuring the circumference off the lower limbs just after awakining and before falling asleep Questionnaires: ICIG FLUTS/MLUTS, PSQI and CIVIQ2
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI
Intervention Type
Diagnostic Test
Intervention Name(s)
Frequency Volume Chart
Intervention Description
Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.
Intervention Type
Diagnostic Test
Intervention Name(s)
Collect urine during 1 day
Intervention Description
Volunteers are asked to collected their urine during the last day of the frequency volume chart. Volunteers get 2 jars: One for collection during the day, and 1 for overnight collection of urine. Osmolality and sodium of urine is tested
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
Blood collection to measure plasma sodium and osmolality.
Intervention Type
Diagnostic Test
Intervention Name(s)
Measurement of the circumference of the lower legs
Intervention Description
Circumference of the lower legs wil be measured twice: After awakening, when still laying dowing in bed Before goin to sleep Circumference should be measured 2 cm above the medial malleolus
Primary Outcome Measure Information:
Title
Change of micturition frequency
Description
Change of the micturition frequency with 1 void
Time Frame
2 months after surgery
Secondary Outcome Measure Information:
Title
Change in nocturnal diuresis
Time Frame
2 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CEAP 2 till 4A Exclusion Criteria: BMI higher than 30 Previous surgery due to venous insufficiency at the lower limbs Cronic edema (Cronic heart failure, liver cirrosis, nefrotic syndrome) Pregnant patient Patients on the following medication: Calcium-antagonists, lithium, NSAID's or corticosteroids, glitazones, insuline, diuretics, sartans, ACE-inhibitors, desmopressine,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Everaert, MD PhD
Organizational Affiliation
UZ Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of urology
City
Ghent
ZIP/Postal Code
8300
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Discovering the Effect of Venous Insufficiency on Nocturia

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