Primary nocturnal enuresis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children over 5 years of age diagnosed with primary nocturnal enuresis (PNE) who are attending the outpatient clinic of the Department of Urology at the Affiliated Children's Hospital of Chongqing Medical University. The diagnosis is based on the criteria set by the International Children's Continence Society (ICCS) and confirmed by a qualified physician. 2. Laboratory results from our hospital indicate that the child's serum vitamin D level is below 35 ng/mL. 3. The child (or guardian) has been fully informed about the nature of the study, understands the study protocol, is capable of ensuring compliance, and has signed an informed consent form. 4. The child (or guardian) is in good psychological health, shows no significant cognitive or communication impairments, and is able to accurately report the child's symptoms and any potential adverse reactions during the treatment.
Exclusion criteria
Exclusion criteria: 1. Presence of other urological malformations or serious medical conditions (e.g., hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urological tumors, urinary stones, bladder and urethral injuries, etc.); 2. Comorbid neurological disorders (e.g., epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, autism spectrum disorder, attention deficit hyperactivity disorder, etc.); 3. Comorbid endocrine disorders (e.g., diabetes mellitus, hyperthyroidism, etc.); 4. Presence of severe heart disease, abnormal liver and kidney function, lung disease, skeletal deformities, severe gastrointestinal disorders, or genetic metabolic diseases; 5. Conditions leading to sleep apnea syndrome (e.g., adenoid hypertrophy, tonsillar hypertrophy, deviated nasal septum, abnormal jaw or maxillofacial development, central sleep apnea, etc.); 6. History of gastrointestinal or urological surgeries; 7. Chronic constipation or dry stools; 8. Use of anticonvulsants, antiepileptic drugs, hormones, or anti-tuberculosis medications; 9. History of hypercalcemia and hyperphosphatemia associated with renal rickets; 10. History of unexplained hematuria or urinary tract infections within the past year; 11. Known allergy or hypersensitivity to vitamin D preparations; 12. Participation in other clinical trials at the time of enrollment or during follow-up; 13. Individuals unwilling to participate or with poor follow-up compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean enuresis frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nocturnal urine volume;Maximum daytime urine volume;Children's sleep disorder scores;Quality of life scores;Change in pediatric lower urinary tract symptom score;Overall Treatment Satisfaction of Pediatric Patients (and Their Families);Treatment Adherence of Pediatric Patients (and Their Families); | — |
Countries
China
Contacts
Children's Hospital of Chongqing Medical University