Nocturnal Enuresis, NE
Conditions
Interventions
Group B:Basic treatment + Transcutaneous Tibial Nerve Stimulation (once a day) for 12 weeks
Group C:Only basic treatment for 12 weeks.
Group A:Basic treatment + Transcutaneous Tibial Nerve Stimulation (once a week) for 12 weeks
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Outpatients with primary enuresis aged 5-14 years; 2. Severe symptoms, enuresis frequency =2 times per week; 3. The children's guardians had been informed of the nature of the study, understood the protocol, were able to ensure compliance, and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with no enuresis for more than 6 consecutive months; 2. Complicated with posterior urethral valve, neurogenic bladder, hypospadias, cryptorchidism, hydronephrosis, renal calculi, urinary tract infection and other urinary system diseases; 3. Patients who had undergone urinary system surgery such as pyeloureteroplasty, enterocystoplasty, urethroplasty, and urethral valve resection; 4. Combined with calcium and phosphorus metabolism disorders, hyperparathyroidism, diabetes mellitus, rickets and other endocrine system diseases; 5. Combined with benign or malignant tumors, gastrointestinal dysfunction, liver and kidney dysfunction, cardiovascular system diseases, nervous system diseases, immune system diseases, skeletal dysplasia or malformation, inherited metabolic diseases, chronic kidney diseases and other severe congenital malformations; 6. Patients with allergy or allergic reaction to tibial nerve stimulation equipment; 7. Taking hormone, antidepressant, antiepileptic, antituberculosis and anticholinergic drugs in the past six months; 8. Patients who received radiotherapy, chemotherapy, immunotherapy or targeted therapy in the past six months; 9. Participating in other clinical investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mean weekly enuresis frequency reduced from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events were monitored;Local adverse reactions: skin erythema, itching, tingling, blisters or local allergic reactions were recorded at the electrode placement site;Nervous system discomfort;Noninvasive urodynamic parameters (urinary flow rate, maximum voiding volume);Changes in urinary microbiome markers; | — |
Countries
China
Contacts
Public ContactYichen Huang
Shanghai Children's Hospital
Outcome results
None listed