Enuresis, NocturnalNESSNCT06488976
Nocturnal Enuresis Symptom Score
An observational study of Enuresis, Nocturnal, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Monosymptomatic nocturnal enuresis (NE), also known as bedwetting, is also defined as intermittent nocturnal enuresis. Nocturnal enuresis is considered primary when a child has not yet been dry for an extended period of time (six months). Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Enuresis, Nocturnal
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 26 Oct 2024
- How long will I take part?
- 12 Months
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients with primary monosymptomatic enuresis nocturna who will be admitted to the pediatric urology outpatient clinic of our center between 15.01.2024-15.10.2024.
Who may be able to join
- Patients with a diagnosis of primary and monosymptomatic enuresis nocturna.
Who cannot join
- Patients with a known urogenital anatomical disorder
- Patients with an additional one lower urinary tract symptom
- Patients that been dry at the nights for >6 months in any time period over the age of 5.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, School of Medicince, Department of Urology, Pediatric Urology Division
Istanbul, Istanbul, 34890
About this study
Official title: Development of a New Scoring System for Enuresis Nocturna: Nocturnal Enuresis Symptom Score (NESS)
Monosymptomatic nocturnal enuresis (NE), also known as bedwetting, is also defined as intermittent nocturnal enuresis.
Nocturnal enuresis is considered primary when a child has not yet been dry for an extended period of time (six months). The term "secondary NE" is used when a child or adult starts wetting again after being dry for at least 6 months.
Read more
Non-monosymptomatic NE is used for patients with lower urinary tract-related voiding symptoms (frequent urination, intermittent voiding, incomplete voiding, urinary tract infection, sudden urge to urinate during the daytime, daytime urinary incontinence).
It is a relatively common symptom in children, with an incidence of 5-10% at the age of seven and 1-2% in adolescents. The ratio of girls to boys has been reported in the literature as roughly 2 to 1.
The annual spontaneous resolution rate is 15% (at any age) and it is considered a relatively benign condition.
Enuresis nocturne has important secondary stressful, emotional and social consequences for children.
Caregivers (caregivers, parents, etc.) of these patients have reported a lower quality of life compared to control groups in studies.
Since children under 5 years of age have a very high probability of spontaneous resolution, the European Society of Urology Guidelines recommend treating children over 5 years of age.
Seven out of 100 seven-year-old bedwetting children will continue to wet the bed in adulthood.
Initially, conservative methods should be recommended, supportive measures including normal and regular eating and drinking habits should be planned, fluid intake should be restricted 3 hours before bedtime and urination should be encouraged by going to the toilet before going to bed at night.
In cases where conservative treatment fails to elicit a response, the child is awakened at a planned time at night with alarm therapy and taken to the toilet to urinate. Thus, it is aimed to empty the urine in the bladder and prevent bedwetting, but with this method, the sleep quality of the child and caregiver is shaken and the quality of life is reduced.
Another treatment method is sublingual desmopressin administration as a medical treatment. The dose frequently used in children has been reported as 120 mcg/day and found to be safe.
In case of dose inadequacy or inadequate response, there are reports showing that 240 mcg desmopressin sublingual treatment is also effective and safe.
Despite sequential and combined treatments, inadequate treatment response may occur in 10-15% of patients or bedwetting symptoms may recur in 25-30% of patients after treatment. In these patients, invasive examinations such as urodynamics and cystoscopy may be planned if necessary, depending on the results of the review after a detailed lower urinary tract function questioning.
There is no questionnaire for primary monosymptomatic enuresis nocturna in the literature. This makes categorization of patients, differential diagnosis, treatment monitoring and response evaluation difficult.
Our aim with this study is that this form will play an active role in categorizing patients and choosing between different treatment modalities at the diagnosis and treatment monitoring stages and will be a helpful tool for clinicians in the future.
Read the detailed description
Primary monsymptomatic enuresis nocturna is defined as unrecognized urinary incontinence at night in children under the age of 18 years and over the age of 5 years, but it is essential to understand that there are no daytime symptoms or voiding symptoms in this disease. In this context, uroflowmetry, residual urine measurement, voiding dysfunction symptom score (VDSS), bladder diary and urinalysis are frequently used in the evaluation of lower urinary tract symptoms in the diagnosis and follow-up stages.
In this clinical study, a symptom questionnaire form will be filled out by asking the relatives and participants with primary monosymptomatic enuresis nocturna who will be admitted to the pediatric urology outpatient clinic between 15.01.2024-15.10.2024. The data and questionnaire results of the first 20 patients (healthy and volunteer) and the reliability and validity of the questionnaire will be statistically evaluated with Cronbach's alpha method and the number of patients will be completed to 200 after the reliability of the questionnaire is completed with this pilot study. Volunteer (healthy) patients will not undergo any additional examination/testing/treatment within the study, except for the physical examination performed in the routine pediatric urology outpatient clinic.
The reason for including healthy volunteers in the study was to measure whether the questionnaire would also be negative in patients who did not complain of nighttime bedwetting. This questionnaire consists of 9 questions in Turkish language and it is planned to mark only one answer per question for each patient. Total scores and answers given per question will be evaluated separately. The results of the tests ordered by our outpatient clinic from patients with a diagnosis of enuresis nocturna will be evaluated by the faculty members of Department of Urology and Division of Pediatric Urology, voiding flow curves and urine volume measurements remaining in the bladder after voiding, frequency-volume measurements in bladder diaries, The severity of enuresis nocturna will be evaluated by noting voiding dysfunction symptom scores (VDSS), renal function tests, complete urine tests, physical examination findings and standard treatments in accordance with the literature and guidelines will be applied (alarm therapy, conservative approaches and desmopressin therapy). It will be investigated whether the scores generated by the forms will be helpful in predicting treatment response and selection. Patients who will be included in the study will not require a re-examination or additional examination/treatment, and no non-standard evaluation will be performed.
- Conditions
- Enuresis, Nocturnal
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enuresis nocturna | Patients older than 5 years of age and the main compliment should be bedwetting without any history of additional lower urinary tract symptoms. | |
| Healthy control | Patients older than 5 years of age, no remarkable past medical history and complaints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal consistency of questionnarre
Form will be analysed by Cronbach's alpha.
Measured: 15.01.2024-01.08.2024
External validation of questionnarre
Form will be applied to another patient population
Measured: 15.01.2024-01.08.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start15 Jan 2024
- Primary completion15 Jun 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enuresis, NocturnalStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488976
- Sponsor's protocol ID
- MAR.UAD.010
- Acronym
- NESS
- Status last verified
- Oct 2024
- First submitted
- 28 Jun 2024
- Last updated
- 29 Oct 2024
- 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Scoring System for Enuresis Nocturna: Nocturnal Enuresis Symptom Score (NESS)
- ClinicalTrials.gov ID
- NCT06488976
- Acronym / sponsor ID
- NESS / MAR.UAD.010
- Conditions
- Enuresis, Nocturnal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 5 Jul 2024 (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.
Monosymptomatic nocturnal enuresis (NE), also known as bedwetting, is also defined as intermittent nocturnal enuresis.
Nocturnal enuresis is considered primary when a child has not yet been dry for an extended period of time (six months). The term "secondary NE" is used when a child or adult starts wetting again after being dry for at least 6 months.
Non-monosymptomatic NE is used for patients with lower urinary tract-related voiding symptoms (frequent urination, intermittent voiding, incomplete voiding, urinary tract infection, sudden urge to urinate during the daytime, daytime urinary incontinence).
It is a relatively common symptom in children, with an incidence of 5-10% at the age of seven and 1-2% in adolescents. The ratio of girls to boys has been reported in the literature as roughly 2 to 1.
The annual spontaneous resolution rate is 15% (at any age) and it is considered a relatively benign condition.
Enuresis nocturne has important secondary stressful, emotional and social consequences for children.
Caregivers (caregivers, parents, etc.) of these patients have reported a lower quality of life compared to control groups in studies.
Since children under 5 years of age have a very high probability of spontaneous resolution, the European Society of Urology Guidelines recommend treating children over 5 years of age.
Seven out of 100 seven-year-old bedwetting children will continue to wet the bed in adulthood.
Initially, conservative methods should be recommended, supportive measures including normal and regular eating and drinking habits should be planned, fluid intake should be restricted 3 hours before bedtime and urination should be encouraged by going to the toilet before going to bed at night.
In cases where conservative treatment fails to elicit a response, the child is awakened at a planned time at night with alarm therapy and taken to the toilet to urinate. Thus, it is aimed to empty the urine in the bladder and prevent bedwetting, but with this method, the sleep quality of the child and caregiver is shaken and the quality of life is reduced.
Another treatment method is sublingual desmopressin administration as a medical treatment. The dose frequently used in children has been reported as 120 mcg/day and found to be safe.
In case of dose inadequacy or inadequate response, there are reports showing that 240 mcg desmopressin sublingual treatment is also effective and safe.
Despite sequential and combined treatments, inadequate treatment response may occur in 10-15% of patients or bedwetting symptoms may recur in 25-30% of patients after treatment. In these patients, invasive examinations such as urodynamics and cystoscopy may be planned if necessary, depending on the results of the review after a detailed lower urinary tract function questioning.
There is no questionnaire for primary monosymptomatic enuresis nocturna in the literature. This makes categorization of patients, differential diagnosis, treatment monitoring and response evaluation difficult.
Our aim with this study is that this form will play an active role in categorizing patients and choosing between different treatment modalities at the diagnosis and treatment monitoring stages and will be a helpful tool for clinicians in the future.
Detailed description
Primary monsymptomatic enuresis nocturna is defined as unrecognized urinary incontinence at night in children under the age of 18 years and over the age of 5 years, but it is essential to understand that there are no daytime symptoms or voiding symptoms in this disease. In this context, uroflowmetry, residual urine measurement, voiding dysfunction symptom score (VDSS), bladder diary and urinalysis are frequently used in the evaluation of lower urinary tract symptoms in the diagnosis and follow-up stages.
In this clinical study, a symptom questionnaire form will be filled out by asking the relatives and participants with primary monosymptomatic enuresis nocturna who will be admitted to the pediatric urology outpatient clinic between 15.01.2024-15.10.2024. The data and questionnaire results of the first 20 patients (healthy and volunteer) and the reliability and validity of the questionnaire will be statistically evaluated with Cronbach's alpha method and the number of patients will be completed to 200 after the reliability of the questionnaire is completed with this pilot study. Volunteer (healthy) patients will not undergo any additional examination/testing/treatment within the study, except for the physical examination performed in the routine pediatric urology outpatient clinic.
The reason for including healthy volunteers in the study was to measure whether the questionnaire would also be negative in patients who did not complain of nighttime bedwetting. This questionnaire consists of 9 questions in Turkish language and it is planned to mark only one answer per question for each patient. Total scores and answers given per question will be evaluated separately. The results of the tests ordered by our outpatient clinic from patients with a diagnosis of enuresis nocturna will be evaluated by the faculty members of Department of Urology and Division of Pediatric Urology, voiding flow curves and urine volume measurements remaining in the bladder after voiding, frequency-volume measurements in bladder diaries, The severity of enuresis nocturna will be evaluated by noting voiding dysfunction symptom scores (VDSS), renal function tests, complete urine tests, physical examination findings and standard treatments in accordance with the literature and guidelines will be applied (alarm therapy, conservative approaches and desmopressin therapy). It will be investigated whether the scores generated by the forms will be helpful in predicting treatment response and selection. Patients who will be included in the study will not require a re-examination or additional examination/treatment, and no non-standard evaluation will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enuresis nocturna | – | –Patients older than 5 years of age and the main compliment should be bedwetting without any history of additional lower urinary tract symptoms. |
| Healthy control | – | –Patients older than 5 years of age, no remarkable past medical history and complaints. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients with primary monosymptomatic enuresis nocturna who will be admitted to the pediatric urology outpatient clinic of our center between 15.01.2024-15.10.2024.
Key inclusion criteria (1 listed)
- Patients with a diagnosis of primary and monosymptomatic enuresis nocturna.
Key exclusion criteria (3 listed)
- Patients with a known urogenital anatomical disorder
- Patients with an additional one lower urinary tract symptom
- Patients that been dry at the nights for >6 months in any time period over the age of 5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal consistency of questionnarre
Time frame: 15.01.2024-01.08.2024
Form will be analysed by Cronbach's alpha.
External validation of questionnarre
Time frame: 15.01.2024-01.08.2024
Form will be applied to another patient population
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 29 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Enuresis, Nocturnal, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 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 29 Oct 2024. 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 Turkey (Türkiye). 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?
Internal consistency of questionnarre (time frame: 15.01.2024-01.08.2024). The study lists 2 primary outcomes in all. 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 29 Oct 2024.