Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder

Launched by THE CHILDREN'S HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · Jan 7, 2025

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed with OAB according to the "Chinese Urology and Male Disease Diagnosis and Treatment Guidelines" 2022 edition;
• • 2. Age between 6 and 18 years, gender unrestricted;
• • 3. Need to receive and consent to TTNS treatment for medical reasons;
• • 4. Urination diary (3 days prior to random enrollment) shows an average of ≥8 urination times per 24 hours;
• • 5. The patient or their representative understands the purpose and requirements of this study and signs the informed consent form (if the subject is \<8 years old, written consent from the legal guardian is required; if the subject is 8 years old ≤ subject ≤ 18 years old, written informed consent from both the subject and the legal guardian is required); If not co-administering β3 agonists/non-selective β-agonists or anticholinergic drugs during the study period, the medication must be discontinued for at least 7 days before the screening period. If continuing to take β3 agonists/non-selective β-agonists or anticholinergic drugs during the study period, the dosage and method of administration must remain unchanged until the study is completed.
• Exclusion Criteria:
• • 1. Those with an implanted pacemaker or implantable cardioverter-defibrillator;
• • 2. Patients with concomitant urinary system diseases: deformities, tumors, obstructions, stones, urinary retention;
• • 3. Patients with stress urinary incontinence and other related diseases affecting urine generation and excretion;
• • 4. Individuals with cognitive impairment, Parkinson's disease, or complete spinal cord injury;
• • 5. Patients with psychiatric disorders who cannot cooperate with medical staff;
• • 6. Patients with pelvic organ prolapse at stage III or higher;
• • 7. Patients who do not have sufficient compliance to cooperate with the treatment and are unable to complete the questionnaires and data collection during the treatment period;
• • 8. Pregnant women or those planning to become pregnant during the study period;
• • 9. Patients who are participating in other clinical studies;
• • 10. Other situations deemed unsuitable for inclusion by the researcher.