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.
Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly.
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.
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.
The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation.
NCT04999657.
European journal of medical research. 2025 Jan 20*** epublish ***
Zhipeng Zhang, Mengzhu Liu, Yangyun Wang, Peng Wu, Yiping Zhu, Bangmin Han, Zhihui Xu, Xudong Li, Chaoliang Shi, Jing Zhang, Deyi Luo, Guowei Shi, Yaoguang Zhang
Department of Urology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, NO.1 DaHua Road, Dong Dan, Beijing, 100730, China., Department of Urology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China., Department of Urology, Shanghai Fifth People's Hospital Affiliated to Fudan University, No.128 Ruili Road, Minhang District, Shanghai, China., Department of Urology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue North, Guangzhou, 510515, Guangdong, China., Department of Urology, Shanghai General Hospital, No. 85/86, Wujin Road, Hongkou District, Shanghai, China., Department of Urology, Zhejiang Provincial People's Hospital, No.158 Shangtang Road, Xiacheng District, Hangzhou, Zhejiang, China., Department of Urology, The First Affiliated Hospital of Xi'an Jiao Tong University, 227 Yanta West Road, Yanta District, Xi'an, Shaanxi, China., Department of Medical Affairs, Floor 4/5, Building 12, No.789 Puxing Road, Minhang District, MedTecXShanghai, China., Department of Urology, West China Hospital, Sichuan University, No.37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, China. ., Department of Urology, Shanghai Fifth People's Hospital Affiliated to Fudan University, No.128 Ruili Road, Minhang District, Shanghai, China. ., Department of Urology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, NO.1 DaHua Road, Dong Dan, Beijing, 100730, China. .