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.

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2025-02-10 DOI:10.1186/s13063-025-08738-5

Zahra Gorji, MohammadReza Hadian Rasanani, Michael Nitsche, Tannaz Ahadi, Roya Khanmohammadi, Mona Gorji, Roxana Bazaz Behbahani, Vahid Rafiei Manesh

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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/ .

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经颅直流电刺激与经皮胫神经刺激对女性膀胱过度活动综合征急症及频率影响的比较：一项随机临床试验的研究方案

背景：膀胱过度活动综合征很常见，在成年人中患病率为12-17%。胫后神经刺激是膀胱过度活动综合征的主要非药物和保守治疗方法。虽然几项人类脑成像研究表明椎管上中枢参与膀胱控制，但一项文献综述发现，没有研究专门研究通过经颅直流电刺激皮质刺激作为治疗女性膀胱过度活跃综合征的方法。因此，本研究旨在评估经颅直流电刺激（tDCS）的潜在益处，并将其与胫后神经刺激对膀胱过度活动综合征的影响进行比较。方法/设计：采用随机分配的方法将参与者分为两组。组1 （n = 19）进行盆底肌肉训练和经皮胫神经刺激。第2组（n = 19）进行盆底肌肉训练和经颅直流电刺激。第二组的经颅直流电刺激将包括12次，每周三次，每次持续20分钟。负极tDCS将针对内侧前额叶皮层（mPFC）进行12次，阴极电极位于Oz和inion之间，强度为2 mA，持续20分钟。人们相信，利用一种涉及非侵入性脑皮层电刺激的方法，可以更有效地治疗膀胱过度活跃的患者。此外，从理论上讲，结合tDCS和盆底肌肉训练的效果可以提供一种减轻膀胱过度活动综合征负面影响的创新技术。最终，这种新方法可以为那些对传统疗法没有反应的患者提供帮助。试验注册：伊朗临床试验注册中心（IRCT） ID: IRCT20090301001722N26，注册日期：2023年5月17日。https://en.irct.ir/。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

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.