An interventional study of Questionnaires and Frequency Volume Chart in Nocturia, Venous Insufficiency of Leg and Fluid Overload, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Diagnostic
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.
134 studies on the registry are indexed under Nocturia; 22 are open to participants now.
This study's enrollment of 84 is above the median of 71 across 108 interventional studies indexed under Nocturia.
Browse Nocturia studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Diagnostic Test: Frequency Volume Chart
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 · 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
ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI
Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.
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 collection to measure plasma sodium and osmolality.
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
Change of micturition frequency
Change of the micturition frequency with 1 void
Time frame: 2 months after surgery
Change in nocturnal diuresis
Time frame: 2 months after surgery
Plan to share: Undecided
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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