Nocturnal Enuresis Symptom Score

NCT06488976 | Completed

• 1 other identifier: MAR.UAD.010
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Enuresis, Nocturnal

Outcome Measures

Primary Outcomes (2)

• Internal consistency of questionnarre

  Form will be analysed by Cronbach's alpha.

  15.01.2024-01.08.2024

• External validation of questionnarre

  Form will be applied to another patient population

  15.01.2024-01.08.2024

Study Arms (2)

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.

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients with a diagnosis of primary and monosymptomatic enuresis nocturna.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University, School of Medicince, Department of Urology, Pediatric Urology Division

Istanbul, Istanbul, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associating Professor, MD

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: January 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: October 26, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

TU (1)