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Discovering the Effect of Venous Insufficiency on Nocturia

NCT04266496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-07-17

No results posted yet for this study

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.

Conditions

  • Nocturia
  • Venous Insufficiency of Leg
  • Fluid Overload

Interventions

OTHER

Questionnaires

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

DIAGNOSTIC_TEST

Frequency Volume Chart

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

DIAGNOSTIC_TEST

Collect urine during 1 day

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

DIAGNOSTIC_TEST

Blood sample

Blood collection to measure plasma sodium and osmolality.

DIAGNOSTIC_TEST

Measurement of the circumference of the lower legs

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

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Karel Everaert, MD PhD · UZ Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-05-28
Completion
2021-05-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04266496 on ClinicalTrials.gov