NocturiaDEVINeNCT04266496
Discovering the Effect of Venous Insufficiency on Nocturia
A study testing Questionnaires, Frequency Volume Chart and Collect urine during 1 day in people with Nocturia and Venous Insufficiency of Leg, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Nocturia, Venous Insufficiency of Leg, Fluid Overload
- What is being tested?
- Questionnaires, Frequency Volume Chart and Collect urine during 1 day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 28 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CEAP 2 till 4A
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discovering the Effect of Venous Insufficiency on Nocturia: a Prospective, Controlled Trail
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
- Being tested
- Questionnaires, Frequency Volume Chart, Collect urine during 1 day, Blood sample, Measurement of the circumference of the lower legs
- Medical subject headings
- Nocturia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI
Frequency Volume ChartDiagnostic test
Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.
Collect urine during 1 dayDiagnostic test
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 sampleDiagnostic test
Blood collection to measure plasma sodium and osmolality.
Measurement of the circumference of the lower legsDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| <2 nocturnal voids | Other | 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 Receives: Other: Questionnaires; Diagnostic Test: Frequency Volume Chart |
| => 2 nocturnal voids | Other | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of micturition frequency
Change of the micturition frequency with 1 void
Measured: 2 months after surgery
Secondary outcomes (1)
Change in nocturnal diuresis
Measured: 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Jan 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Everaert, MD PhD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266496
- Sponsor's protocol ID
- BC-6121
- Acronym
- DEVINe
- Status last verified
- Jul 2023
- First submitted
- 10 Feb 2020
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering the Effect of Venous Insufficiency on Nocturia: a Prospective, Controlled Trail
- ClinicalTrials.gov ID
- NCT04266496
- Acronym / sponsor ID
- DEVINe / BC-6121
- Conditions
- Nocturia, Venous Insufficiency of Leg, Fluid Overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| <2 nocturnal voids | Other | Other: Questionnaires, Diagnostic Test: Frequency Volume ChartAll 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 |
| => 2 nocturnal voids | Other | 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 legsAll 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 |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CEAP 2 till 4A
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI | Other | <2 nocturnal voids, => 2 nocturnal voids |
| Frequency Volume ChartCollect a frequency volume chart for 3 days: measure the amount of voids and volume urinated. | Diagnostic test | <2 nocturnal voids, => 2 nocturnal voids |
| Collect urine during 1 dayVolunteers 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 | => 2 nocturnal voids |
| Blood sampleBlood collection to measure plasma sodium and osmolality. | Diagnostic test | => 2 nocturnal voids |
| Measurement of the circumference of the lower legsCircumference 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 | Diagnostic test | => 2 nocturnal voids |
Primary outcome
Change of micturition frequency
Time frame: 2 months after surgery
Change of the micturition frequency with 1 void
1 secondary outcome
Change in nocturnal diuresis
Time frame: 2 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Everaert, MD PhD principal investigator
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Frequency Volume Chart and Collect urine during 1 day in people with Nocturia and Venous Insufficiency of Leg, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of micturition frequency (time frame: 2 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.