Nocturnal EnuresisCOMENNCT02621736
Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).
An observational study of Nocturnal Enuresis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigmatism. The only available medical treatment option is the vasopressin analogum Desmopressin®. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- blood sampling
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2016to 30 Jun 2021
- Phase
- Observational
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children at the Age of 5-16 years with monosymptomatic enuresis nocturna
Who may be able to join
- Children at the age between 5 and 16 years
- Diagnosis of monosymptomatic nocturnal enuresis
- Completion of uroflowmetry and bladder sonography if possible
- Completion of home recording charts of bed wetting episodes if possible
- Willingness to use Desmopressin® treatment
Who cannot join
- Children with daytime enuresis
- Children with lower urinary tract symptoms and infection
- Children with structural abnormalities of the urinary tract
- Children with chronic illness, esp. renal failure, hypertension, congenital heart disease, diabetes mellitus and diabetes insipidus.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigmatism.
The only available medical treatment option is the vasopressin analogum Desmopressin®. However, according to the literature, only one third of patients shows a good treatment response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side effects like water intoxication and hypertension.
Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in patients with MEN compared to controls and lower in patients with severe bed wetting compared to patients with only slight bed wetting.
- Conditions
- Nocturnal Enuresis
- Being tested
- blood sampling
- Keywords
- children, desmopressin, copeptin
- Medical subject headings
- Nocturnal Enuresis, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
At 4 visits capillary blood sampling for copeptin measurement will be performed with each child.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of copeptin at baseline and after 28 days during routine desmopressin therapy
Measured: morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start1 Jan 2016
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Professor, Principal investigator, University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621736
- Sponsor's protocol ID
- EK 2015-340
- Acronym
- COMEN
- Status last verified
- Dec 2021
- First submitted
- 25 Nov 2015
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).
- ClinicalTrials.gov ID
- NCT02621736
- Acronym / sponsor ID
- COMEN / EK 2015-340
- Conditions
- Nocturnal Enuresis
- Keywords
- children, desmopressin, copeptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigmatism.
The only available medical treatment option is the vasopressin analogum Desmopressin®. However, according to the literature, only one third of patients shows a good treatment response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side effects like water intoxication and hypertension.
Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in patients with MEN compared to controls and lower in patients with severe bed wetting compared to patients with only slight bed wetting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children at the Age of 5-16 years with monosymptomatic enuresis nocturna
Key inclusion criteria (5 listed)
- Children at the age between 5 and 16 years
- Diagnosis of monosymptomatic nocturnal enuresis
- Completion of uroflowmetry and bladder sonography if possible
- Completion of home recording charts of bed wetting episodes if possible
- Willingness to use Desmopressin® treatment
Key exclusion criteria (4 listed)
- Children with daytime enuresis
- Children with lower urinary tract symptoms and infection
- Children with structural abnormalities of the urinary tract
- Children with chronic illness, esp. renal failure, hypertension, congenital heart disease, diabetes mellitus and diabetes insipidus.
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 |
|---|---|---|
| blood samplingAt 4 visits capillary blood sampling for copeptin measurement will be performed with each child. | Other | – |
Primary outcome
Change of copeptin at baseline and after 28 days during routine desmopressin therapy
Time frame: morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy
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 13 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Mirjam Christ-Crain, Professor principal investigator
University Hospital Basel, Department of Endocrinology, Diabetes and Metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturnal Enuresis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 4 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 13 Dec 2021. 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 Switzerland. 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 copeptin at baseline and after 28 days during routine desmopressin therapy (time frame: morning and evening copeptin levels at baseline day 0 before routine desmopressin therapy and day 28 during routine desmopressin therapy). 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 13 Dec 2021.