Comparison of the effects of transcranial direct current stimulation and transcutaneous tibial nerve stimulation on the urgency and frequency of women with overactive bladder syndrome: study protocol of a randomized clinical trial.
Zahra Gorji, MohammadReza Hadian Rasanani, Michael Nitsche, Tannaz Ahadi, Roya Khanmohammadi, Mona Gorji, Roxana Bazaz Behbahani, Vahid Rafiei Manesh
{"title":"Comparison of the effects of transcranial direct current stimulation and transcutaneous tibial nerve stimulation on the urgency and frequency of women with overactive bladder syndrome: study protocol of a randomized clinical trial.","authors":"Zahra Gorji, MohammadReza Hadian Rasanani, Michael Nitsche, Tannaz Ahadi, Roya Khanmohammadi, Mona Gorji, Roxana Bazaz Behbahani, Vahid Rafiei Manesh","doi":"10.1186/s13063-025-08738-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Overactive bladder syndrome is common, with a prevalence of 12-17% among adults. Posterior tibial nerve stimulation is the primary nonpharmacological and conservative treatment for overactive bladder syndrome. While several human brain imaging studies have shown the involvement of supraspinal centers in bladder control, a literature review has found that no research has specifically investigated cortical stimulation through transcranial direct current stimulation as a treatment for overactive bladder syndrome in women. Therefore, this study aims to assess the potential benefits of transcranial direct current stimulation (tDCS) and compare them with the effects of posterior tibial nerve stimulation on overactive bladder syndrome.</p><p><strong>Methods/design: </strong>The random allocation method will be used to divide the participants into two groups. Group 1 (n = 19) will undergo pelvic floor muscle training and transcutaneous tibial nerve stimulation. Group 2 (n = 19) will undergo pelvic floor muscle training and transcranial direct current stimulation. The transcranial direct current stimulation for group 2 will consist of 12 sessions occurring thrice a week, each lasting for 20 min. Anodal tDCS will be administered to FPz targeting the medial prefrontal cortex (mPFC) for 12 sessions, with the cathode electrode positioned between Oz and inion at an intensity of 2 mA for 20 min.</p><p><strong>Discussion: </strong>It is believed that utilizing an approach involving non-invasive electrical stimulation of the cortex could lead to a more efficient treatment for individuals with overactive bladder. Additionally, it is theorized that combining the effects of tDCS and pelvic floor muscle training could present an innovative technique for alleviating the negative impacts of overactive bladder syndrome. Ultimately, this new method could provide help for patients who have not responded to conventional therapy.</p><p><strong>Trial registration: </strong>Iranian Registry of Clinical Trials (IRCT) ID: IRCT20090301001722N26, registration date: May 17, 2023. https://en.irct.ir/ .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"48"},"PeriodicalIF":2.0000,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11809105/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-025-08738-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Overactive bladder syndrome is common, with a prevalence of 12-17% among adults. Posterior tibial nerve stimulation is the primary nonpharmacological and conservative treatment for overactive bladder syndrome. While several human brain imaging studies have shown the involvement of supraspinal centers in bladder control, a literature review has found that no research has specifically investigated cortical stimulation through transcranial direct current stimulation as a treatment for overactive bladder syndrome in women. Therefore, this study aims to assess the potential benefits of transcranial direct current stimulation (tDCS) and compare them with the effects of posterior tibial nerve stimulation on overactive bladder syndrome.
Methods/design: The random allocation method will be used to divide the participants into two groups. Group 1 (n = 19) will undergo pelvic floor muscle training and transcutaneous tibial nerve stimulation. Group 2 (n = 19) will undergo pelvic floor muscle training and transcranial direct current stimulation. The transcranial direct current stimulation for group 2 will consist of 12 sessions occurring thrice a week, each lasting for 20 min. Anodal tDCS will be administered to FPz targeting the medial prefrontal cortex (mPFC) for 12 sessions, with the cathode electrode positioned between Oz and inion at an intensity of 2 mA for 20 min.
Discussion: It is believed that utilizing an approach involving non-invasive electrical stimulation of the cortex could lead to a more efficient treatment for individuals with overactive bladder. Additionally, it is theorized that combining the effects of tDCS and pelvic floor muscle training could present an innovative technique for alleviating the negative impacts of overactive bladder syndrome. Ultimately, this new method could provide help for patients who have not responded to conventional therapy.
Trial registration: Iranian Registry of Clinical Trials (IRCT) ID: IRCT20090301001722N26, registration date: May 17, 2023. https://en.irct.ir/ .
期刊介绍:
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.