NCT04266496

Discovering the Effect of Venous Insufficiency on Nocturia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nocturia
• Venous Insufficiency of Leg
• Fluid Overload

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	Blood sample	Blood collection to measure plasma sodium and osmolality.
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2020-02-12
• Last updated: 2023-07-17

Locations

1 site across 1 country: Belgium