Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Venous Insufficiency of Leg; Nocturia; Fluid Overload

Treatments: Diagnostic Test: Blood sample; Diagnostic Test: Collect urine during 1 day; Other: Questionnaires; Diagnostic Test: Frequency Volume Chart; Diagnostic Test: Measurement of the circumference of the lower legs

Study type: Interventional

Funder types: Other

Identifiers

NCT04266496

BC-6121

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

<2 nocturnal voids

Other group

Description:

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

Treatment:

Other: Questionnaires

Diagnostic Test: Frequency Volume Chart

=> 2 nocturnal voids

Other group

Description:

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

Treatment:

Diagnostic Test: Measurement of the circumference of the lower legs

Other: Questionnaires

Diagnostic Test: Frequency Volume Chart

Diagnostic Test: Blood sample

Diagnostic Test: Collect urine during 1 day