Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488976
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
Nocturnal Enuresis Symptom Score
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Development of a New Scoring System for Enuresis Nocturna Nocturnal Enuresis Symptom Score NESS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NESS
Brief 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 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 mcgday 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
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 mcgday 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 families and themselves of patients with primary monosymptomatic enuresis nocturna who will be admitted to the pediatric urology outpatient clinic of our center between 15012024-15102024 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 Cronbachs 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 examinationtestingtreatment 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 our centers 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 examinationtreatment and no non-standard evaluation will be performed
In this clinical study a symptom questionnaire form will be filled out by asking the families and themselves of patients with primary monosymptomatic enuresis nocturna who will be admitted to the pediatric urology outpatient clinic of our center between 15012024-15102024 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 Cronbachs 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 examinationtestingtreatment 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 our centers 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 examinationtreatment and no non-standard evaluation will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None