Zhang Zhipeng, Liu Mengzhu, Wang Yangyun, Wu Peng, Zhu Yiping, Han Bangmin, Xu Zhihui, Li Xudong, Shi Chaoliang, Zhang Jing, Luo Deyi, Shi Guowei, Zhang Yaoguang
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.
Eur J Med Res. 2025 Jan 20;30(1):40. doi: 10.1186/s40001-024-02262-z.
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.
评估一种非侵入性低频胫神经刺激器（TNS - 01）与假对照相比，在缓解膀胱过度活动症（OAB）患者症状方面的疗效和安全性。
被诊断为原发性OAB或表现出至少一种OAB症状的参与者。所有参与者每周接受三次30分钟的干预疗程。
受试者按1:1随机分组（采用4个区组的区组随机化）至积极治疗组（TNS - 01组）或假治疗组（假手术组）。根据随机分组情况，受试者将被给予一个有源或假的设备系统（系统仅在使用说明和电极尺寸/形状上有所不同）。在为期12周的研究期间，所有参与者每周接受三次30分钟的干预疗程。主要终点是第12周时膀胱过度活动症症状评分（OABSS）相对于基线的变化。
在招募的109例OAB患者中。在TNS - 01组中，第12周时OABSS相对于基线的变化显著高于假手术组（2.83±2.53对1.62±2.59，p = 0.02）。在第8周时，TNS - 01组每天平均急迫性尿失禁发作次数相对于基线的绝对变化和百分比变化均显著低于假手术组（0.11±1.33对0.68±2.14，p = 0.01； - 27.82%±167.33%对87.18%±25.20%，p = 0.04）。假手术组有1例患者（1.8%）报告了1例与治疗相关的不良事件（血尿）。
TNS - 01设备在刺激12周后缓解OAB症状方面有效且安全。
NCT04999657。
