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Discovering the Effect of Venous Insufficiency on Nocturia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04266496
Acronym
DEVINe
Enrollment
84
Registered
2020-02-12
Start date
2020-01-01
Completion date
2021-05-28
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia, Venous Insufficiency of Leg, Fluid Overload

Brief 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.

Interventions

OTHERQuestionnaires

ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI

DIAGNOSTIC_TESTFrequency Volume Chart

Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.

DIAGNOSTIC_TESTCollect 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_TESTBlood sample

Blood collection to measure plasma sodium and osmolality.

DIAGNOSTIC_TESTMeasurement 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

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Change of micturition frequency2 months after surgeryChange of the micturition frequency with 1 void

Secondary

MeasureTime frame
Change in nocturnal diuresis2 months after surgery

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026