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- Title
Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial.
- Authors
Zhishun Liu; Yan Liu; Huanfang Xu; Liyun He; Yuelai Chen; Lixin Fu; Ning Li; Yonghui Lu; Tongsheng Su; Jianhua Sun; Jie Wang; Zenghui Yue; Wei Zhang; Jiping Zhao; Zhongyu Zhou; Jiani Wu; Kehua Zhou; Yanke Ai; Jing Zhou; Ran Pang
- Abstract
<bold>Importance: </bold>Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited.<bold>Objective: </bold>To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI.<bold>Design, Setting, and Participants: </bold>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.<bold>Interventions: </bold>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.<bold>Main Outcomes and Measures: </bold>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).<bold>Results: </bold>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.<bold>Conclusions and Relevance: </bold>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.<bold>Trial Registration: </bold>clinicaltrials.gov Identifier: NCT01784172.
- Subjects
CHINA; ELECTROACUPUNCTURE; URINARY incontinence in women; TREATMENT effectiveness; CHINESE women; PSYCHOLOGICAL stress; PHYSIOLOGICAL stress; HEALTH; THERAPEUTICS; TREATMENT of urinary stress incontinence; ACUPUNCTURE points; BACK; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; RESEARCH; STATISTICAL sampling; TIME; URINARY stress incontinence; EVALUATION research; RANDOMIZED controlled trials; DISEASE incidence
- Publication
JAMA: Journal of the American Medical Association, 2017, Vol 317, Issue 24, p2493
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2017.7220