Journal Article

Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder

Han, Bangmin, Zhu, Yiping, Zhang, Zhipeng, Shi, Chaoliang, Xu, Zhihui, Luo, Deyi, Liu, Mengzhu, Zhang, Jing, Li, Xudong, Shi, Guowei, Wang, Yangyun, Wu, Peng, Zhang, Yaoguang

2025

Overview

Objectives To evaluate the efficacy and safety of a non-invasive low-frequency tibial nerve stimulator (TNS-01) vs sham control in relieving the symptoms of overactive bladder (OAB) patients. Patients Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly. Methods The subjects were 1:1randomized (block randomization with a block size of 4) to either active treatment (TNS-01 group) or sham treatment (sham group). Based on the randomization, the subject will be given either an active or sham device system (systems will only differ in the Instructions for Use and electrode size/shape). During the 12-week study period, all participants underwent three 30-min intervention sessions weekly. The primary endpoint was the change in Overactive Bladder Symptom Score (OABSS) at week 12 from the baseline. Results Of the 109 recruited OAB patients. In the TNS-01 group, the OABSS change from baseline at week 12 was significantly higher than that in the sham group (2.83 ± 2.53 vs 1.62 ± 2.59, p  = 0.02). The absolute and percent changes of average UUI episodes per day from baseline at week 8 in the TNS-01 group were significantly lower from those in the sham group (0.11 ± 1.33 vs 0.68 ± 2.14, p  = 0.01; − 27.82% ± 167.33% vs 87.18% ± 25.20%, p  = 0.04). One treatment-related adverse event (hematuria) was reported by one patient (1.8%) in the sham group. Conclusions The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation. Trial registration number: NCT04999657.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adrenergic receptors / Adult / Aged / Agonists / Biomedicine / Bladder / Diaries / Efficacy / Electric Stimulation Therapy - adverse effects / Electric Stimulation Therapy - methods / Electrodes / Female / Health aspects / Humans / Infectious Diseases / Internal Medicine / Intervention / Male / Medical equipment / Medical research / Medicine / Medicine & Public Health / Middle Aged / Nocturia / Non-invasive low-frequency tibial nerve stimulator / Oncology / Overactive bladder / Patient compliance / Patient satisfaction / Questionnaires / Randomized clinical trial / Safety / Software / Statistical analysis / Surgery / Tibial Nerve - physiopathology / Transcutaneous Electric Nerve Stimulation - methods / Treatment Outcome / Trospium / Urinary Bladder, Overactive - physiopathology / Urinary Bladder, Overactive - therapy / Urinary incontinence / Urogenital system