Atak Çakir Pinar, Mutluay Fatma, Hanoğlu Lütfü, Güzelburç Vahit
Department of Physiotherapy and Rehabilitation, Institute of Health Sciences, Istanbul Medipol University, Istanbul, Turkey.
Neurology Department, Istanbul Medipol University, Istanbul, Turkey.
Front Neurol. 2022 Oct 28;13:1011502. doi: 10.3389/fneur.2022.1011502. eCollection 2022.
Neurogenic bladder is frequently seen in patients with multiple sclerosis (MS). Electrical stimulation methods (neuromodulation) can be used for patients that have persistent symptoms despite pharmacological treatment. This study aims to compare the effects of two different neuromodulation techniques used in the treatment of neurogenic bladder.
This is a single-center randomized controlled trial for MS patients with neurogenic bladder. Patients determined to be eligible according to the study criteria will be randomized into two treatment groups: the transcutaneous posterior tibial nerve stimulation (PTNS) and repetitive transcranial magnetic stimulation (rTMS) groups. Each group will include eight patients. The patients will be treated for a total of 10 sessions for two consecutive weeks. The pressure-flow study will be used to compare the initial and final urodynamic results as the primary outcome. All the participants will fill in a 3-day bladder diary before and after the treatments in each group. Patients will also be asked to complete specific questionnaires for incontinence and quality of life (QOL): Overactive Bladder Questionnaire-V8 score (OAB-V8), Incontinence Severity Index (ISI), Incontinence Quality of Life Scale score (I-QOL), International Incontinence Questionnaire (ICIQ-SF) score, and International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) score) as the secondary outcomes.
An ethical approval number was obtained from the Non-Invasive Clinical Research Ethics Committee of Istanbul Medipol University (ethical approval number: 768). Support was received within the scope of the Istanbul Medipol University Scientific Research Project with project number 2020-2017. The result of this study will be published in a peer-reviewed journal.
NCT05312138.
神经源性膀胱在多发性硬化症（MS）患者中很常见。对于药物治疗后仍有持续症状的患者，可采用电刺激方法（神经调节）。本研究旨在比较两种不同神经调节技术治疗神经源性膀胱的效果。
这是一项针对患有神经源性膀胱的MS患者的单中心随机对照试验。根据研究标准确定符合条件的患者将被随机分为两个治疗组：经皮胫后神经刺激（PTNS）组和重复经颅磁刺激（rTMS）组。每组将包括8名患者。患者将连续两周共接受10次治疗。压力-流率研究将用于比较初始和最终尿动力学结果，作为主要结局。所有参与者将在每组治疗前后填写一份为期3天的膀胱日记。还将要求患者完成关于尿失禁和生活质量（QOL）的特定问卷：膀胱过度活动症问卷-V8评分（OAB-V8）、尿失禁严重程度指数（ISI）、尿失禁生活质量量表评分（I-QOL）、国际尿失禁咨询问卷（ICIQ-SF）评分以及国际尿失禁咨询问卷-女性下尿路症状（ICIQ-FLUTS）评分，作为次要结局。
获得了伊斯坦布尔梅迪波尔大学非侵入性临床研究伦理委员会的伦理批准号（伦理批准号：768）。在伊斯坦布尔梅迪波尔大学科研项目（项目编号：2020 - 2017）范围内获得了支持。本研究结果将发表在同行评审期刊上。
NCT05312138。
