Skip to main content
OpenTrials
Completed

NCT Number: NCT04266496

Discovering the Effect of Venous Insufficiency on Nocturia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nocturia Edema Fluid Overload Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations Venous Insufficiency of Leg

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of urology

Ghent, 8300, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

questionnaires

Other

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

Frequency Volume Chart

Diagnostic Test

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

Collect urine during 1 day

Diagnostic 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

Blood sample

Diagnostic Test

Blood collection to measure plasma sodium and osmolality.

Measurement of the circumference of the lower legs

Diagnostic 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

Primary outcomes

  1. Change of micturition frequency

    Time frame: 2 months after surgery

    Change of the micturition frequency with 1 void

Secondary outcomes

  1. Change in nocturnal diuresis

    Time frame: 2 months after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Discovering the Effect of Venous Insufficiency on Nocturia: a Prospective, Controlled Trail

Acronym: DEVINe

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2020
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.