Enuresis
Conditions
Brief summary
This prospective, randomized, two-arm, parallel-design controlled clinical trial aims to determine whether high-dose vitamin D supplementation combined with alarm therapy improves outcomes in children with primary monosymptomatic nocturnal enuresis compared to alarm therapy alone.
Detailed description
Nocturnal enuresis (NE) is characterized by recurrent involuntary urination during sleep in children aged 5 years and older, persisting for over three months with at least two episodes per week. This condition, resulting from the child's inability to awaken from sleep, exhibits a prevalence rate ranging from 4.8% to 15.2%, which notably declines with age. Moreover, NE significantly impacts the psychological well-being and overall quality of life of affected individuals. The primary treatments for NE include desmopressin acetate (DDAVP) and behavioral interventions (BI). While these modalities offer therapeutic benefits, their implementation is often prolonged and fraught with challenges, including adverse drug reactions and a high rate of symptom recurrence after treatment discontinuation. These factors complicate adherence for both patients and their families. Patients with NE are more likely to suffer from vitamin D deficiency. This study aims to determine the effect of vitamin D supplementation as an adjunctive therapy to alarm therapy in the treatment of primary monosymptomatic nocturnal enuresis(PMNE). Eligible patients aged 5-18 years with a diagnosis of NE will be randomly assigned to receive either high-dose vitamin D supplementation combined with alarm therapy or alarm therapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptom severity will be assessed at baseline and follow-up, along with other sociodemographic data. This study will provide more information on the role of vitamin D supplementation in managing PMNE.
Interventions
BEHAVIORALalarm therapy
These patients will receive alarm therapy for 8 weeks.
DRUGVitamin D3
These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) (combined with alarm therapy) for 8 weeks.
Sponsors
Xing Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 5-18 years diagnosed with PMNE-defined as intermittent urinary incontinence during sleep in a children who are never dry for more than 6 months and have no other lower urinary tract symptoms-according to the latest International Children's Continence Society guidelines, presenting at outpatient urology clinics. * Serum vitamin D level below 30 ng/mL. * Written informed consent obtained from each participant and their guardian. * Adequate psychological and cognitive function, no communication barriers, and ability to accurately report symptoms and potential adverse reactions during treatment.
Exclusion criteria
* Urological malformations or serious urological disease, such as hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, or bladder/urethral injuries. * Neurological disorders, including epilepsy, spinal cord injury or dysplasia, spinal embolism syndrome, multiple sclerosis, autism spectrum disorder, or attention-deficit/hyperactivity disorder. * Endocrine diseases, such as diabetes mellitus or hyperthyroidism. * Severe systemic disease, including significant cardiac disease, renal or hepatic insufficiency, pulmonary disease, bone deformities, gastrointestinal disorders, or inherited metabolic disorders. * Conditions predisposing to sleep apnea, such as adenoid or tonsillar hypertrophy, deviated nasal septum, craniofacial abnormalities, or central sleep apnea. * History of gastrointestinal or urological surgery. * Use of anticonvulsant, antiepileptic, corticosteroid, or anti-tuberculosis medications. * History of hypercalcemia, hyperphosphatemia, or renal rickets. * Unexplained hematuria or urinary tract infection within the past year. * Allergy to vitamin D formulations. * Concurrent participation in other clinical studies. * Unwillingness to participate or poor anticipated follow-up compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response after interventions | 8 weeks | Response rate: defined as a ≥50% reduction in the number of wet nights per week |
| Complete response after interventions | 8 weeks | The rate of complete response was defined as a 100% reduction in wet nights per week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in enuresis frequency | 8 weeks | Change in enuresis frequency from baseline to follow-up |
| Change in quality of life score | 8 week | The quality of life was assessed using a scale ranging from 0 to 3, where a score of 0 indicated no impact on family, social, or academic life, a score of 1 indicated occasional impact, a score of 2 indicated significant impact, and a score of 3 indicated severe impact on family, social, or academic life. |
| Change in vitamin D level | 8 week | Change in vitamin D level from baseline to follow-up |
| Change in serum levels of calcium | 8 weeks | Change in serum levels of calcium from baseline to follow-up |
| Global perception of improvement | 8 week | Global perception of improvement (much better; better; about the same; worse) |
| Wish to receive another form of treatment? | 8 week | Wish to receive another form of treatment? (YES; No) |
| Treatment adherence | 8 week | The extent to which a patient adheres to their medication schedule, including both timing and dosage, or follows the prescribed treatment regimen |
| Incidence of side effects | 8 week | Type and frequency of side effects during treatment |
Countries
China
Contacts
STUDY_DIRECTORXing Liu, Doctor
Children's Hospital of Chongqing Medical University
Outcome results
None listed