NCT04266496

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

February 10, 2020

Last Update Submit

July 14, 2023

Conditions

NocturiaVenous Insufficiency of LegFluid Overload

Outcome Measures

Primary Outcomes (1)

  • Change of micturition frequency

    Change of the micturition frequency with 1 void

    2 months after surgery

Secondary Outcomes (1)

  • Change in nocturnal diuresis

    2 months after surgery

Study Arms (2)

<2 nocturnal voids

OTHER

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

Other: QuestionnairesDiagnostic Test: Frequency Volume Chart

=> 2 nocturnal voids

OTHER

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

Other: QuestionnairesDiagnostic Test: Frequency Volume ChartDiagnostic Test: Collect urine during 1 dayDiagnostic Test: Blood sampleDiagnostic Test: Measurement of the circumference of the lower legs

Interventions

QuestionnairesOTHER

ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI

<2 nocturnal voids=> 2 nocturnal voids
Frequency Volume ChartDIAGNOSTIC_TEST

Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.

<2 nocturnal voids=> 2 nocturnal voids
Collect urine during 1 dayDIAGNOSTIC_TEST

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

=> 2 nocturnal voids
Blood sampleDIAGNOSTIC_TEST

Blood collection to measure plasma sodium and osmolality.

=> 2 nocturnal voids
Measurement of the circumference of the lower legsDIAGNOSTIC_TEST

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

=> 2 nocturnal voids

Eligibility Criteria

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

You may qualify if:

  • CEAP 2 till 4A

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of urology

Ghent, 8300, Belgium

Location

MeSH Terms

Conditions

NocturiaEdema

Interventions

Surveys and QuestionnairesBlood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, Operative

Study Officials

  • Karel Everaert, MD PhD

    UZ Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 12, 2020

Study Start

January 1, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

July 17, 2023

Record last verified: 2023-07

Locations

BE(1)