Pediatric Over Active Bladder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age =16 years, regardless of gender; (2) Meets the diagnostic criteria for refractory OAB; (3) Agrees to receive treatment with a wearable percutaneous tibial nerve stimulator; (4) Voluntarily participates in this clinical trial and signs the informed consent form; (5) Voiding diary (recorded for 3 days prior to randomization) indicates an average of =8 voids per 24 hours.
Exclusion criteria
Exclusion criteria: (1)Children with implanted cardiac pacemakers or defibrillators (as electrical stimulation may impact the safety of the devices); (2)Presence of uncontrolled symptomatic urinary tract infection, urolithiasis, urinary tuberculosis, or bladder tumors; (3)Children with renal insufficiency (serum creatinine levels exceeding 1.5 times the upper limit of normal); (4)Children with epilepsy, acute cerebrovascular disease, cognitive impairment, complete spinal cord injury, or psychiatric disorders; (5)Skin lesions at the treatment site that preclude stimulation; (6)Presence of other comorbidities that could affect the efficacy of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Voiding Diary;OAB Symptom Score; | — |
Countries
China
Contacts
Children‘s Hospital of Nanjing Medical University