Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 317; no. 24; pp. 2493 - 2501
• Main Authors: Liu, Zhishun, Liu, Yan, Xu, Huanfang, He, Liyun, Chen, Yuelai, Fu, Lixin, Li, Ning, Lu, Yonghui, Su, Tongsheng, Sun, Jianhua, Wang, Jie, Yue, Zenghui, Zhang, Wei, Zhao, Jiping, Zhou, Zhongyu, Wu, Jiani, Zhou, Kehua, Ai, Yanke, Zhou, Jing, Pang, Ran, Wang, Yang, Qin, Zongshi, Yan, Shiyan, Li, Hongjiao, Luo, Lin, Liu, Baoyan
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 27.06.2017
• Subjects: Acupuncture; Acupuncture Points; Adult; Aged; Bladder; China; Clinical trials; Data collection; Electroacupuncture; Electroacupuncture - adverse effects; Electroacupuncture - methods; Electroacupuncture - statistics & numerical data; Female; Humans; Incidence; Intervention; Leakage; Lumbosacral Region; Middle Aged; Original Investigation; Skin; Stress; Stresses; Time Factors; Treatment Outcome; Urinary bladder; Urinary incontinence; Urinary Incontinence, Stress - epidemiology; Urinary Incontinence, Stress - therapy; Urine; Women; Womens health
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2017.7220

IMPORTANCE: Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited. OBJECTIVE: To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015. INTERVENTIONS: Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. MAIN OUTCOMES AND MEASURES: The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes). RESULTS: Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (−9.9 g) than the sham electroacupuncture group (−2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild. CONCLUSIONS AND RELEVANCE: Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01784172.