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Safety and Efficacy of Transcutaneous Tibial Nerve Stimulation in Children With Overactive Bladder: A Prospective, Multicenter, Single-Arm Study
Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequency and nocturia, with or without urge incontinence, without urinary tract infection or other clear pathological changes. The prevalence of OAB ranges from 9% to 43% in women and 7% to 27% in men, severely affecting patients' quality of life and mental health. Traditional treatments for OAB include behavioral therapy (bladder retraining, pelvic floor muscle training, etc.) and drug therapy (including anticholinergic, antispasmodic drugs, and tricyclic antidepressants, etc.); for refractory overactive bladder syndrome, surgical interventions include bladder augmentation and urinary diversion, etc. However, due to serious complications, lack of efficacy, or significant trauma, these methods are greatly limited in clinical application. In recent years, with the continuous development of neuromodulation technology, neurostimulation has gradually been applied in the treatment of lower urinary tract dysfunction. Compared with traditional treatments, it does not have side effects such as dry mouth, constipation, blurred vision, etc., and compared with surgical treatment, it reduces side effects such as bleeding and infection. Among them, Tibial Nerve Stimulation (TNS) has become an optional therapy for OAB treatment due to its non-surgical nature, convenience, low risk, high safety, significant efficacy, and relative cost-effectiveness. With the continuous development of technology, and in order to reduce the invasiveness of treatment, improve safety and convenience, Percutaneous Tibial Nerve Stimulation (PTNS) is gradually shifting towards non-invasive Percutaneous Tibial Nerve Stimulation (TTNS). The main difference between the two is that the former uses fine needle electrodes, while the latter mostly uses surface electrodes, which deliver electrical power to the tibial nerve through skin and soft tissue. Studies have shown that TTNS has the same efficacy as drug therapy, is more effective for OAB symptoms than behavioral interventions, and there is no statistically significant difference in efficacy between TTNS and PTNS. It is recommended as an option to improve OAB by the "European Association of Urology Guidelines on Female Non-neurogenic LUTS (2023)" and the "Chinese Guidelines on Diagnosis and Treatment of Urology and Male Diseases (2022)". However, there is still a lack of large-scale prospective studies on the use of TTNS for OAB in Asian populations, and most existing studies have observation periods of 3 months or less, lacking high-quality research evidence for long-term efficacy. Therefore, a prospective, multicenter, single-arm study is planned to verify the long-term efficacy of percutaneous tibial nerve stimulation in the treatment of OAB in the Chinese population.
Age
6 - 18 years
Sex
ALL
Healthy Volunteers
No
Department of Urology, Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Start Date
March 9, 2024
Primary Completion Date
January 1, 2026
Completion Date
January 1, 2027
Last Updated
January 9, 2025
200
ESTIMATED participants
Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group
DEVICE
Lead Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Collaborators
NCT07193407
NCT07195656
NCT07391878
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