Discovering the Effect of Venous Insufficiency on Nocturia

Not Applicable

Completed

• Conditions: Nocturia; Venous Insufficiency of Leg; Fluid Overload
• Interventions: 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

• Registration Number: NCT04266496
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
=> 2 nocturnal voids	Frequency Volume Chart	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
=> 2 nocturnal voids	Collect urine during 1 day	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
<2 nocturnal voids	Questionnaires	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
=> 2 nocturnal voids	Measurement of the circumference of the lower legs	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
<2 nocturnal voids	Frequency Volume Chart	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
=> 2 nocturnal voids	Questionnaires	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
=> 2 nocturnal voids	Blood sample	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

Primary Outcome Measures

Name	Time	Method
Change of micturition frequency	2 months after surgery	Change of the micturition frequency with 1 void

Secondary Outcome Measures

Name	Time	Method
Change in nocturnal diuresis	2 months after surgery

Trial Locations

Locations (1)

Department of urology; 🇧🇪 Ghent, Belgium