Discovering the Effect of Venous Insufficiency on Nocturia
NCT ID: NCT04266496
Last Updated: 2023-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2020-01-01
2021-05-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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<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
Questionnaires
ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI
Frequency Volume Chart
Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.
=> 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
Questionnaires
ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI
Frequency Volume Chart
Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.
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
Blood sample
Blood collection to measure plasma sodium and osmolality.
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
Interventions
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Questionnaires
ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI
Frequency Volume Chart
Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.
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
Blood sample
Blood collection to measure plasma sodium and osmolality.
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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,
25 Years
60 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Karel Everaert, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Ghent
Locations
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Department of urology
Ghent, , Belgium
Countries
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Other Identifiers
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BC-6121
Identifier Type: -
Identifier Source: org_study_id
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