Xu Lin, Fu Chenying, Zhang Qing, Xiong Feng, Peng Lihong, Liang Zejun, Chen Li, He Chengqi, Wei Quan
Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.
Key Laboratory of Rehabilitation Medicine in Sichuan Province, Chengdu, Sichuan, PR China.
BMJ Open. 2020 Aug 5;10(8):e034582. doi: 10.1136/bmjopen-2019-034582.
Neurogenic bladder dysfunction is prevalent in female patients with spinal cord injury (SCI), and previous guidelines have recommended pelvic floor muscle training (PFMT) for first-line conservative treatment. However, the actual regimen of PFMT varies widely and the single treatment does not satisfy the need of some patients. Therefore, this study aims to provide a detailed rationale and methodology for comparing the effectiveness of PFMT, biofeedback and repetitive transcranial magnetic stimulation (rTMS) as adjunct treatments for neurogenic bladder dysfunction.
This trial is a single-centre randomised controlled trial for female patients with urinary incontinence (UI) in phase of chronic SCI. Eligible participants will be randomised to one of four arms: (1) PFMT, (2) PFMT with biofeedback, (3) PFMT and rTMS and (4) PFMT with biofeedback and rTMS. There will be 44 participants in each arm and all the subjects will undergo 20 treatment sessions, five times a week for 4 weeks. The outcomes will be evaluated at 4 weeks, 3 months and 6 months after randomisation. The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.
The Clinical Research and Biomedical Ethics Committee of the West China Hospital, Sichuan University has approved this trial and the approval number is 2019-885. All participants will be provided written informed consent after verification of the eligibility criteria. The results of this study will be accessible in peer-reviewed publications and be presented at academic conferences.
Chinese Clinical Trial Registry (ChiCTR1900026126).
神经源性膀胱功能障碍在脊髓损伤（SCI）女性患者中很常见，既往指南推荐盆底肌肉训练（PFMT）作为一线保守治疗方法。然而，PFMT的实际方案差异很大，单一治疗不能满足部分患者的需求。因此，本研究旨在提供详细的理论依据和方法，以比较PFMT、生物反馈和重复经颅磁刺激（rTMS）作为神经源性膀胱功能障碍辅助治疗的有效性。
本试验是一项针对慢性SCI期女性尿失禁（UI）患者的单中心随机对照试验。符合条件的参与者将被随机分为四组之一：（1）PFMT，（2）PFMT联合生物反馈，（3）PFMT和rTMS，（4）PFMT联合生物反馈和rTMS。每组将有44名参与者，所有受试者将接受20次治疗，每周5次，共4周。在随机分组后4周、3个月和6个月进行结局评估。主要结局是国际尿失禁咨询委员会尿失禁简表，次要结局包括膀胱日记、盆底肌肉功能和国际脊髓损伤生活质量基本数据集。
四川大学华西医院临床研究与生物医学伦理委员会已批准本试验，批准号为2019 - 885。在核实纳入标准后，将为所有参与者提供书面知情同意书。本研究结果将在同行评审的出版物上发表，并在学术会议上展示。
中国临床试验注册中心（ChiCTR1900026126）
