Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload; Venous Insufficiency of Leg; Nocturia
• Intervention / Treatment: Other: Questionnaires; Diagnostic test: Frequency Volume Chart; Diagnostic test: Collect urine during 1 day; Diagnostic test: Blood sample; Diagnostic test: Measurement of the circumference of the lower legs

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim Pauwaert, MD; Phone Number: 0476213954; Email: kim.pauwaert@ugent.be
• Study Contact Backup: Name: Karel Everaert, MD PhD; Email: Karel.Everaert@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium, 8300
    • Department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: <2 nocturnal voids; 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: 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.
Other: => 2 nocturnal voids; 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of micturition frequency	Change of the micturition frequency with 1 void	2 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in nocturnal diuresis	2 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Karel Everaert, MD PhD, UZ Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Venous Insufficiency; Nocturia
• Other Study ID Numbers: BC-6121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No