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NCT04266496 Clinical Trial

Discovering the Effect of Venous Insufficiency on Nocturia

Fluid Overload Clinical Trial

— DEVINe  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04266496
Other study ID # BC-6121
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date May 28, 2021

Study information
Verified date July 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date May 28, 2021
Est. primary completion date May 28, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• 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

Locations
Country Name City State
Belgium Department of urology Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of micturition frequency Change of the micturition frequency with 1 void 2 months after surgery
Secondary Change in nocturnal diuresis 2 months after surgery
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