| OBJECTIVETo evaluate the efficiency and safety of electro-acupuncture for decreasing incontinence episodes of women with moderate and severe stress urinary incontinence.METHODSThis prospective,randomized,parallel-controlled trial assigned women with moderate and severe stress urinary incontinence into electro-acupuncture and sham electro-acupuncture randomly with 1:1 ratio.The period of this trial was 31weeks,including a baseline period of 1week,a treatment period of 6 weeks and a follow-up period of 24 weeks.All the participants were treated every other day,received 3 times treatment every week and 18 times treatment in total.The primary outcome was the proportion of participants with at least 50%decrease from baseline at the end of 6 weeks of treatment.Secondary outcomes included the proportion of participants with at least 50%decrease from baseline at the other visit viewpoints,the amount of urine leakage measured by 1-hour pad test,the change from baseline in the amount of urine leakage measured by 1-hour pad test,the mean 72-hour urinary incontinence episodes,the mean 24-hour urinary incontinence episodes after the first treatment and the validated Chinese version International Consultation on Incontinence Questionnaire-Short Form scores,Sandvik severity index in female urinary incontinence and participant expectation.RESULTSThis trial included 40 participants totally and 20 participants were in the electro-acupuncture group and 20 participants in the sham electro-acupuncture.The primary outcome:Effectiveness was defined as the proportion of participants with at least 50%decrease from baseline at the end of 6 weeks of treatment,the effective rate of electro-acupuncture group was44.40%and the effective rate of sham electro-acupuncture group was 50.50%.There was no statistical difference between two groups during the treatment period(P>0.05).Secondary outcomes:? Effectiveness was defined as the proportion of participants with at least 50%decrease from baseline at the other visit viewpoints.At the end of 2 weeks of treatment,the effective rate of electro-acupuncture group was 5.00%and the effective rate of sham electro-acupuncture group was 0.00%.At the end of 4 weeks of treatment,the effective rate of electro-acupuncture group was 55.60%and the effective rate of sham electro-acupuncture group was 55.00%.At the end of 17 weeks of follow-up,the effective rate of electro-acupuncture group was 91.67%and the effective rate of sham electro-acupuncture group was 87.5%.At the end of 18 weeks of follow-up,the effective rate of electro-acupuncture group was 75.00%and the effective rate of sham electro-acupuncture group was 42.86%.At the end of 29 weeks of follow-up,the effective rate of electro-acupuncture group was 85.71%and the effective rate of sham electro-acupuncture group was 75.00%.At the end of 30weeks of follow-up,the effective rate of electro-acupuncture group was 85.71%and the effective rate of sham electro-acupuncture group was 75.00%.There was no statistical difference between two groups during the follow-up period(P>0.05).? At the end of 2 weeks of treatment,the change from baseline in the mean 72-hour urinary incontinence episodes was 0.50(1.83)(M(QR))in the electro-acupuncture group and-1.17(2.75)(M(QR))in the sham electro-acupuncture group,and the difference between two groups was 1.05(95%CI-0.26-2.36).At the end of 4 weeks of treatment,the change from baseline in the mean72-hour urinary incontinence episodes was-1.57(95%CI-2.54,-0.61)in the electro-acupuncture group and-2.02(95%CI-2.90,-1.14)in the sham electro-acupuncture group,and the difference between two groups was 0.62(95%CI-0.82,1.70).At the end of 6 weeks of treatment,the change from baseline in the mean 72-hour urinary incontinence episodes was-2(95%CI-2.90,-1.10)in the electro-acupuncture group and-2.33(95%CI-3.13,-1.54)in the sham electro-acupuncture group,and the difference between two groups was 0.33(95%CI-0.83,1.50).At the end of 17 weeks of follow-up,the change from baseline in the mean 72-hour urinary incontinence episodes was-8.42(95%CI-13.27,-3.56)in the electro-acupuncture group and-10.75(95%CI-17.82,-3.67)in the sham electro-acupuncture group,and the difference between two groups was 2.33(95%CI-5.32,9.98).At the end of 18weeks of follow-up,the change from baseline in the mean 72-hour urinary incontinence episodes was-5(10)(M(QR))in the electro-acupuncture group and-8.14(95%CI-14.84,-1.44)in the sham electro-acupuncture group,and the difference between two groups was 0.48(95%CI-7.22,8.17).At the end of 29 weeks of follow-up,the change from baseline in the mean 72-hour urinary incontinence episodes was-7(95%CI-14.08,0.83)in the electro-acupuncture group and-6.50(30.25)(M(QR))in the sham electro-acupuncture group,and the difference between two groups was-4.25(95%CI-20.39,11.89).At the end of 30 weeks of follow-up,the change from baseline in the mean 72-hour urinary incontinence episodes was-7.14(95%CI-14.32,0.30)in the electro-acupuncture group and-6.50(29.50)(M(QR))in the sham electro-acupuncture group,and the difference between two groups was-0.14(95%CI-15.72,15.44).During the treatment and follow-up period,within the group comparison,both groups had statistical differences compared with baseline(P<0.05),but there was no statistical difference between two groups(P>0.05).?At the end of 6 weeks treatment,the proportion of participants with at least 50%decrease from baseline in the amount of urine leakage measured by 1-hour pad test was61.10%in the electro-acupuncture group and 43.80%in the sham electro-acupuncture group.There was no statistical difference between two groups(P>0.05).?At the end of 6 weeks,the change from baseline in the amount of urine leakage measured by 1-hour pad test was-0.59(95%CI,-0.80,-0.38)in the electro-acupuncture group and-0.29(95%CI-0.65,0.18)in the sham electro-acupuncture group.The difference between two groups was-0.35(95%CI,-0.78,0.08).Within the group comparison,both groups had statistical differences compared with baseline(P<0.05),but there was no statistical difference between two groups(P>0.05).?The change from baseline in the mean 24-hour urinary incontinence episodes after the first treatment was-0.08(95%CI-0.80,0.64)in the electro-acupuncture group and-0.17(95%CI-0.45,0.10)in the sham electro-acupuncture group.The difference between two groups was 0.09(95%CI-0.61,0.79).Within the group comparison,both groups had statistical differences compared with baseline(P<0.05),but there was no statistical difference between two groups(P>0.05).?Sandvik severity index in female urinary incontinence:At the end of 6 weeks treatment,33.33%participants were mild,61.11%participants were medium and 5.56%participants were severe in the electro-acupuncture group;0.00%participants were mild,81.25%participants were medium and 18.75%participants were severe in the sham electro-acupuncture group.There was statistical difference between two groups(P<0.05).At the end of 18 weeks follow-up,25.00%participants were mild,66.67%participants were medium and 8.33%participants were severe in the electro-acupuncture group;28.57%participants were mild,28.57%participants were medium and 42.86%participants were severe in the sham electro-acupuncture group.At the end of 30weeks follow-up,57.14%participants were mild,28.57%participants were medium and 14.29%participants were severe in the electro-acupuncture group;25.00%participants were mild,50.00%participants were medium and 25.00%participants were severe in the sham electro-acupuncture group.There was statistical difference between two groups during the follow-up period(P<0.05).?At the end of 6 weeks treatment,the change from baseline of International Consultation on IncontinenceQuestionnaire-Short Form scores was-7.06(95%CI,-9.31,-4.80)in the electro-acupuncture group and-4.25(95%CI,-5.96,-2.54)in the sham electro-acupuncture group.Within the group comparison,both groups had statistical differences compared with baseline(P<0.05).The difference between two groups was-2.81(95%CI,-5.58,-0.02)and there was statistical difference between two groups(P<0.05).At the end of 18 weeks follow-up,the change from baseline of International Consultation on Incontinence Questionnaire-Short Form scores was-6.42(95%CI-9.04,-3.80)in the electro-acupuncture group and-4.57(95%CI-7.23,-1.91)in the sham electro-acupuncture group.The difference between two groups was-1.85(95%CI-5.59,1.90).At the end of 30 weeks follow-up,the change from baseline of International Consultation on Incontinence Questionnaire-Short Form scores was-7.29(95%CI-10.39,-4.19)in the electro-acupuncture group and-4.5(9.50)(M(QR))in the sham electro-acupuncture group.The difference between two groups was-3.29(95%CI-8.91,2.33).During the treatment and follow-up period,within the group comparison,both groups had statistical differences compared with baseline(P<0.05),but there was no statistical difference between two groups(P>0.05).?Participant expectation:At the end of 6weeks treatment,there was statistical difference between two groups(P<0.05).During the follow-up period,there was no statistical difference between two groups(P>0.05).?There was no statistical difference between two groups about blind method evaluation(P>0.05).The blind process was successful.?Between the two groups,there was no serious adverse event.The incidence of adverse event was 15.00%in electro-acupuncture group and 0.00%in sham electro-acupuncture group.CONCLUSIONThis exploratory experiment suggests that both electro-acupuncture and sham electro-acupuncture can decrease incontinence episodes of women with moderate and severe stress urinary incontinence,but there was no obvious difference between electro-acupuncture and sham electro-acupuncture.Both electro-acupuncture and sham electro-acupucnture may decrease the amount of urine leakage measured by 1-hour pad test,Sandvik severity index in female urinary incontinence and International Consultation on Incontinence Questionnaire-Short Form scores,or increase participant evaluation.In these respects,electro-acupuncture may be better than sham electro-acupuncture.As an exporatory trial,small sample size may lead to bias,so the interpretation should be cautious. |
PDF Full Text Request