{"title":"无创低频胫神经刺激器治疗膀胱过动症的疗效及安全性。","authors":"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","doi":"10.1186/s40001-024-02262-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Patients: </strong>Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation.</p><p><strong>Trial registration number: </strong>NCT04999657.</p>","PeriodicalId":11949,"journal":{"name":"European Journal of Medical Research","volume":"30 1","pages":"40"},"PeriodicalIF":2.8000,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748249/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder.\",\"authors\":\"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\",\"doi\":\"10.1186/s40001-024-02262-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Patients: </strong>Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation.</p><p><strong>Trial registration number: </strong>NCT04999657.</p>\",\"PeriodicalId\":11949,\"journal\":{\"name\":\"European Journal of Medical Research\",\"volume\":\"30 1\",\"pages\":\"40\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2025-01-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748249/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Medical Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s40001-024-02262-z\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Medical Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s40001-024-02262-z","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
摘要
目的：评价无创低频胫神经刺激器（TNS-01）与假对照在缓解膀胱过动症（OAB）患者症状中的疗效和安全性。患者：被诊断为原发性OAB或表现出至少一种OAB症状的参与者。所有参与者每周进行三次30分钟的干预。方法：将受试者按1:11随机（分组随机，分组大小为4）分为积极治疗组（TNS-01组）和假手术组（假手术组）。在随机化的基础上，受试者将被给予有源或假设备系统（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，所有参与者每周进行三次30分钟的干预。主要终点是第12周膀胱过度活动症状评分（OABSS）较基线的变化。结果：109例OAB患者中。TNS-01组第12周OABSS较基线变化显著高于sham组（2.83±2.53 vs 1.62±2.59,p = 0.02）。与假手术组相比，TNS-01组第8周每天平均UUI发作数的绝对变化和百分比明显降低(0.11±1.33 vs 0.68±2.14,p = 0.01；- 27.82%±167.33% vs 87.18%±25.20%,p = 0.04)。假手术组1例患者（1.8%）报告了1例治疗相关不良事件（血尿）。结论：刺激12周后，TNS-01装置可有效、安全缓解OAB症状。试验注册号：NCT04999657。
Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder.
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.
期刊介绍：
European Journal of Medical Research publishes translational and clinical research of international interest across all medical disciplines, enabling clinicians and other researchers to learn about developments and innovations within these disciplines and across the boundaries between disciplines. The journal publishes high quality research and reviews and aims to ensure that the results of all well-conducted research are published, regardless of their outcome.
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