NCT06765629

Transcutaneous Tibial Nerve Stimulation Therapy in Children With Overactive Bladder

ENROLLING BY INVITATION NA Last updated 9 January 2025

What this trial tests

NA trial testing Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group in Overactive Bladder (OAB) in 200 participants. Enrolling by invitation.

Timeline

9 March 2024

Primary endpoint
1 January 2026

1 January 2027

Quick facts

Lead sponsor	The Children's Hospital of Zhejiang University School of Medicine
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	9 March 2024
Primary completion	1 January 2026
Estimated completion	1 January 2027
Sites	1 location across China

Drugs / interventions tested

• Non-invasive Percutaneous Tibial Nerve Stimulation (TTNS) group

Conditions studied

• Overactive Bladder (OAB) — all drugs for Overactive Bladder (OAB) →

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Who can join

Adults 6 to 18, any sex, with Overactive Bladder (OAB). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.