Electroacupuncture involving the lumbosacral region is safe, well-tolerated, and can reduce the amount of urine leakage in women with stress urinary incontinence, researchers reported.
Electroacupuncture (EA) involving the lumbosacral region is safe, well-tolerated, and can reduce the amount of urine leakage in women with stress urinary incontinence (SUI), according to findings of a randomized sham-controlled clinical trial.
Conducted by researchers at 12 hospitals in China, the study, which was published in JAMA (2017; 317:2493-2501), included 504 women assigned 1:1 to receive a 6-week course of EA or a sham procedure, each involving 18 30-minute sessions. Follow-up continued for an additional 24 weeks.
Change from baseline to week 6 in the amount of urine leakage measured by the 1-hour pad test was analyzed as the primary endpoint, and the results showed statistically significant superiority of EA. Mean urine leakage in the EA and sham groups at baseline was 18.4 g and 19.1 g, respectively, and was decreased at week 6 by 9.9 g and 2.6 g, respectively (mean difference, 7.4 g; p<.001). The proportion of women achieving a clinically important ≥50% reduction in urine leakage from baseline was three-fold greater in the EA group compared with sham (64.6% vs. 21.7%; p<.001).
The EA effect occurred early-mean decrease in urine leakage from baseline to week 2 was significantly greater in the EA group compared with sham-and as demonstrated by results of other secondary outcomes, it persisted to week 30. Analyses of change in mean number of 72-hour incontinence episodes during weeks 1-6, 15-18, 27-30, the proportion of patients with a ≥50% reduction in mean 72-hour incontinence episodes from baseline during weeks 1-6, 15-18, 27-30, and change in International Consultation on Incontinence Questionnaire-Short Form score from baseline to week 6, 18, and 30 all showed statistically significant differences favoring EA over sham.
“The effect of EA for SUI has been explored in previous studies, but its benefit remained uncertain because the earlier investigations had limitations, such as small sample size, poor design, and high risk of bias. Our study is a well-designed, multicenter, randomized, controlled clinical trial with a large number of participants. Furthermore, the gold standard for efficacy evaluation used in our trial was clinically meaningful and recognized worldwide,” said senior author Baoyan Liu, MD, of Guang’an Men Hospital, which is affiliated with the China Academy of Chinese Medical Sciences in Beijing.
“Our strictly performed randomized controlled trial confirmed the efficacy and safety of EA for decreasing urinary leakage in women with SUI, and the effect in reducing urinary incontinence episodes of EA during the 24-week follow-up period was comparable to that reported for pelvic floor muscle training. Considering our findings, we believe that EA performed by a trained acupuncturist and using our regimen should be recommended as a conservative therapy for the female patient with SUI, especially for anyone who is not a good surgical candidate or who has failed pelvic floor muscle training.”
Patient retention in the study was good. Of the 504 women who were randomized to treatment, 482 (95.6%) completed the trial. No patient in the EA group dropped out because of an adverse event, and the incidence of treatment-related adverse events in the EA group was only 1.6%.
The investigators are continuing research to study the use of EA for female SUI. In the future, they plan to conduct a study that will evaluate change of incontinence episodes as the primary outcome measure. In addition, they are considering conducting randomized controlled clinical trials with longer follow-up and evaluating EA in women with mixed urinary incontinence.
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