Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder
Abstract 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. Al...
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BMC
2025-01-01
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| Series: | European Journal of Medical Research |
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| Online Access: | https://doi.org/10.1186/s40001-024-02262-z |
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| author | 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 |
| author_facet | 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 |
| author_sort | Zhipeng Zhang |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-b4e7555099f4467db2abc39d09172cd5 |
| institution | Kabale University |
| issn | 2047-783X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMC |
| record_format | Article |
| series | European Journal of Medical Research |
| spelling | doaj-art-b4e7555099f4467db2abc39d09172cd52025-01-26T12:21:50ZengBMCEuropean Journal of Medical Research2047-783X2025-01-0130111210.1186/s40001-024-02262-zEfficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladderZhipeng Zhang0Mengzhu Liu1Yangyun Wang2Peng Wu3Yiping Zhu4Bangmin Han5Zhihui Xu6Xudong Li7Chaoliang Shi8Jing Zhang9Deyi Luo10Guowei Shi11Yaoguang Zhang12Department of Urology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical SciencesDepartment of Urology, West China Hospital, Sichuan UniversityDepartment of Urology, Shanghai Fifth People’s Hospital Affiliated to Fudan UniversityDepartment of Urology, Nanfang Hospital, Southern Medical UniversityDepartment of Urology, Shanghai General HospitalDepartment of Urology, Shanghai General HospitalDepartment of Urology, Zhejiang Provincial People’s HospitalDepartment of Urology, The First Affiliated Hospital of Xi’an Jiao Tong UniversityDepartment of Urology, Shanghai Fifth People’s Hospital Affiliated to Fudan UniversityDepartment of Medical AffairsDepartment of Urology, West China Hospital, Sichuan UniversityDepartment of Urology, Shanghai Fifth People’s Hospital Affiliated to Fudan UniversityDepartment of Urology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical SciencesAbstract 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.https://doi.org/10.1186/s40001-024-02262-zOveractive bladderNon-invasive low-frequency tibial nerve stimulatorEfficacySafetyRandomized clinical trial |
| spellingShingle | 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 Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder European Journal of Medical Research Overactive bladder Non-invasive low-frequency tibial nerve stimulator Efficacy Safety Randomized clinical trial |
| title | Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder |
| title_full | Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder |
| title_fullStr | Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder |
| title_full_unstemmed | Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder |
| title_short | Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder |
| title_sort | efficacy and safety of non invasive low frequency tibial nerve stimulator in overactive bladder |
| topic | Overactive bladder Non-invasive low-frequency tibial nerve stimulator Efficacy Safety Randomized clinical trial |
| url | https://doi.org/10.1186/s40001-024-02262-z |
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