Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.
Department of acupuncture and moxibustion, Chongqing hospital of traditional Chinese medicine, Chongqing, China.
BMC Complement Med Ther. 2020 Jul 16;20(1):224. doi: 10.1186/s12906-020-03018-y.
Overactive bladder is defined as "urgency, with or without urge incontinence, usually with frequency and nocturia". Electroacupuncture may be a safe and an effective alternative therapy for overactive bladder, but the evidence is limited.
We will conduct a three-arm, non-inferiority, multi-centre randomized controlled clinical trial. A total of 420 patients with moderate and severe overactive bladder will be randomly assigned to one of three groups: the electroacupuncture group (N = 140), sham electroacupuncture group (N = 140), and solifenacin group (N = 140). The primary outcome will be the change in the overactive bladder symptom score from baseline to the end of the 12-week treatment. The secondary outcomes will include the proportion of participants with a decrease in the overactive bladder symptom score ≥ 3 at weeks 4, 8, 12, 20, and 32; the change in average 24 h values of urination, nocturnal urination, urgency incontinence and urgency episodes from baseline to weeks 4, 8, 12, 20 and 32, and so forth. The adverse events will be recorded. Statistical analysis will include covariance analysis, nonparametric tests and descriptive statistics.
This study will answer the question of whether electroacupuncture is effective and non-inferior to solifenacin for improving the symptoms of overactive bladder patients.
Chinese clinical trial registry ( ChiCTR1800019928 ).
膀胱过度活动症被定义为“伴有或不伴有急迫性尿失禁的尿急，通常伴有尿频和夜尿”。电针可能是治疗膀胱过度活动症的一种安全有效的替代疗法，但证据有限。
我们将进行一项三臂、非劣效性、多中心随机对照临床试验。将 420 例中重度膀胱过度活动症患者随机分为三组：电针组（N=140）、假电针组（N=140）和索利那新组（N=140）。主要结局将是从基线到 12 周治疗结束时膀胱过度活动症症状评分的变化。次要结局包括第 4、8、12、20 和 32 周时膀胱过度活动症症状评分下降≥3的参与者比例；从基线到第 4、8、12、20 和 32 周时平均 24 小时排尿次数、夜间排尿次数、急迫性尿失禁和急迫性发作次数的变化等。将记录不良反应。统计分析将包括协方差分析、非参数检验和描述性统计。
这项研究将回答电针是否有效且不劣于索利那新改善膀胱过度活动症患者症状的问题。
中国临床试验注册中心（ChiCTR1800019928）。
