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

ClinConnect Summary

This study is looking at whether a non-surgical, wearable device that stimulates a nerve near the ankle (transcutaneous tibial nerve stimulation, or TTNS) is safe and helpful for children with overactive bladder (OAB). It’s a prospective, multicenter study in China and will enroll about 200 kids ages 6 to 18 who have been diagnosed with OAB and who urinate ≥8 times in a 24-hour period. To join, the child and/or their guardian must agree to participate, and there are specific rules about who can participate (for example, no implanted pacemakers, certain urinary or neurological conditions, pregnancy, or inability to follow study procedures).

If you participate, you’ll wear a small TTNS device on the ankle area, guided by a mobile app, after signing consent. Researchers will track your symptoms over time, using a 72-hour diary of urination and several questionnaires about bladder symptoms, quality of life, and anxiety. These measurements are planned for 1 month, 2 months, 3 months, 6 months, and 1 year after starting treatment. This is a single-arm study (no comparison group) being led by The Children’s Hospital of Zhejiang University School of Medicine in Hangzhou, with several collaborating centers, and results are expected to help understand long-term use of TTNS for OAB in Chinese children. The study began recruitment in 2024 and is planned to continue through early 2027.

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.