Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
Clinical Research Section, Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China.
BMJ Open. 2018 Nov 5;8(11):e021783. doi: 10.1136/bmjopen-2018-021783.
Electroacupuncture at 'four sacral points', also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at 'four sacral points' for the management of urinary incontinence after stroke.
This is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at 'four sacral points' along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.
This protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059-01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.
ChiCTR-IOR-17012847; Pre-result.
电针“骶四穴”，又称阴部神经电刺激疗法，结合了阴部神经神经调节和深刺长针技术的优点。既往研究中，该方法已被用于治疗压力性尿失禁、女性尿急-频综合征、特发性急迫性尿失禁和神经源性膀胱。在此，我们描述了一项评估电针“骶四穴”治疗中风后尿失禁疗效和安全性的随机对照试验方案。
这是一项开放标签、随机对照试验，评估和分析均设盲。共纳入 140 例符合条件的患者，随机分为两组。治疗组（n=70）将接受电针“骶四穴”联合常规医疗护理，对照组（n=70）将接受常规电针联合常规医疗护理。治疗共 20 次，为期 4 周。主要结局指标为基线和基线后 4 周时失禁发作日记中的自我记录结果。次要结局指标为国际尿失禁咨询问卷尿失禁-短表（ICIQ-UI SF）评分和基线、基线后 4 周和 28 周时的巴氏日常生活活动指数（Barthel ADL Index）评分。
该方案已获得浙江中医药大学第一附属医院伦理委员会的批准（批准号：2018-K-059-01）。将获得每位参与者的书面知情同意。研究结果将发表在同行评议的期刊上。
ChiCTR-IOR-17012847；预注册。
