Discovering the Effect of Venous Insufficiency on Nocturia

Study Overview
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Brief Summary
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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.

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

Conditions
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Nocturia, Venous Insufficiency of Leg, Fluid Overload

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: <2 nocturnal voids<br>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<br>* ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI<br>Diagnostic Test: Frequency Volume Chart<br>* Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.<br>|
| Other: => 2 nocturnal voids<br>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<br>* ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI<br>Diagnostic Test: Frequency Volume Chart<br>* Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.<br>Diagnostic Test: Collect urine during 1 day<br>* 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<br>Diagnostic Test: Blood sample<br>* Blood collection to measure plasma sodium and osmolality.<br>Diagnostic Test: Measurement of the circumference of the lower legs<br>* 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<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nocturnal diuresis |  | 2 months after surgery |