| BackgroundMixed urinary incontinence(MUI)can be subdivided into urgency-predominant MUI,stress-predominant MUI and balanced MUI.Since the physiopathology under urgency-predominant MUI is rather complex and the urgency symptoms is difficult to be suppressed consciously,the impact of urgency-predominant MUI on quality of life is greater than any other types of urinary incontinence(UI).There is still a lack of therapy targeted at MUI recommended in guidelines.Antimuscarinic drugs,which is the first line therapy for pure urgency urinary incontinence(UUI),has always been applied to treat urgency-predominant MUI in clinic.However,patients tend to discontinue the drugs out of the frequently occurred adverse events,resulted in uncertain clinical effects.Our previous clinical trials indicated that electroacupuncture is effective in the treatment of MUI,with a good safety profile.The effectiveness of electroacupuncture is noninferior to antimuscarinic drug of solifenacin plus pelvic floor muscle training(PFMT).However,population with all the three types of MUI were included in previous clinical trial,thus the effectiveness of acupuncture on urgency-predominant MUI has not been determined specifically.Contents and aimsResearch a.To lay a research foundation for future randomized controlled trial,a secondary analysis of previous clinical trial was performed to address the effectiveness of electroacupuncture on urgency-predominant MUI and estimated the effect size.Research b.A perspective,multicentered randomized controlled trial was performed among women with urgency-predominant MUI to determine whether the effectiveness of electroacupuncture is superior to solifenacin.Research c.Analysis was made among the population received electroacupuncture treatment in those two clinical trials to explore the factors that may influence the effects immediately after treatment and 24 weeks after treatment of electroacupuncture for urgency-predominant.MethodsResearch a.Data of population with urgency-predominant MUI was extracted.The outcome was the proportion of participants with a reduction of 50%or more urinary incontinence episodes over 72 hours from baseline to week 12.Research b.A multicenter randomized controlled trial was performed in five sites over China.315 women with urgency-predominant MUI were centrally randomized in a 1:1:1 ration to electroacupuncture group,solifenacin group or minimal electroacupuncture group.Participants in electroacupuncture and minimal electroacupuncture group receive 36-session acupuncture treatment over 12 weeks,followed by 24-week follow-up without treatment;while population in the solifenaicn group received 36-week treatment with cessation.The primary outcome was the proportion of participants with a reduction of 50%or more urinary incontinence episodes over 72 hours from baseline to week 12.Research c.In accordance with whether the reduction of urinary incontinence episodes over 72 hours from baseline to week 12 reached 50%or not,the participants in the electroacupuncture group of those two clinical trials were classified into responder and non-responder.Full model and backward regression with bootstrap method was used to explore whether the effects immediately after treatment can be influenced by the factors of age,parturition,body mass index(BMI),menopause,complication,urinary incontinence episodes and micturition episodes.Clinically meaningful objective outcome and subjective outcomes were both applied to assess how long the effectiveness of electroacupuncture can sustain.Additionally,full model and backward regression with bootstrap method was used to explore whether the sustained effects can be influenced by the factors of age,parturition,body mass index(BMI),menopause,complication,urinary incontinence episodes and micturition episodes.ResultsResearch a.178 women with urgency-predominant MUI were included in the secondary analysis,of which 83 was in the electroacupuncture group and 95 was in the PFMT plus solifenacin group.After 12-week treatment,the proportion of participants with the reduction of 50%or more urinary incontinence episodes over 72 hours from baseline to 12 weeks was 65.06 in the electroacupuncture group,a little lower than the 68.89 in the solifenacin group.The between-group difference was-3.83(95%CI:17.85 to 10.20),without statistical significance(P=0.59).Research b.At present,a total of 148 women with urgency-predominant MUI was included in the randomized controlled trial,of which 115 has completed 12-week follow-up and 48 has completed 36-week follow-up.After 12-week treatment,the proportion of participants with the reduction of 50%or more urinary incontinence episodes over 72 hours from baseline was 77.78(28/36)in the electroacupuncture group,higher than the 46.34(19/41)in the solifenacin group.The between-group difference was 31.4(95%CI:11.0 to 51.9),with statistical significance(P=0.005).The proportion of participants with the reduction of 50%or more urinary incontinence episodes over 72 hours from baseline was 68.42(26/38)in the minimal electroacupuncture group.The proportion in the electroacupuncture group was higher than the minimal electroacupuncture group,with between-group difference was 9.4(95%CI:-10.7 to 29.4),without statistical significance(P=0.36).The proportion in the solifenacin group was lower than the minimal electroacupuncture group,with betweengroup difference was-22.1(95%CI:-43.3 to-0.8),with statistical significance(P=0.04).Research c.A total of 97 participants were included in the analysis,of which 64 was responder and 33 was non-responder.BMI and complication were the factor that may influence the immediate effects after treatment of electroacupuncture.Women with BMI less than 27 tend to acquire effects than those with BMI larger than 27,with OR 0.79(0.67 to 0.94).Patients without complication or less complication tend to acquire effects,with OR 8.47(1.04 to 69.35).Menopause,urinary incontinence episodes or micturition episodes do not influence the immediate effects of electroacupuncture after 12-week treatment on urgency-predominant MUI.After 24-week follow-up without treatment,95.31%(61/64)participants in the responder group maintained clinically meaningful response,higher than the proportion of 48.48%(16/33)in the non-responder group,with a between-group difference of 46.83%(29.01 to 64.65,P<0.001).81.25%(52/64)participants in the responder group still perceived moderate or marked satisfaction towards symptom improvement,higher than the proportion of 54.55%(18/33)in the non-responder group,with a betweengroup difference of 26.70%(95%CI:7.21 to 46.20)P=0.005).BMI was the factor that may influence the sustained effects of electroacupuncture.Women with BMI less than 27 tend to retained sustained effects than those with BMI larger than 27,with OR 0.81(95%CI:0.69 to 0.95).Menopause,complication,urinary incontinence episodes or micturition episodes do not influence the sustained effects of electroacupuncture on urgency-predominant MUI.ConclusionsResearch a.The effectiveness of electroacupuncture is superior to solifenacin in the treatment of urgency-predominant MUI among women with a rather good safety profile.It can be recommended as a therapy for urgency-predominant MUI in clinic.Research b.The effectiveness of electroacupuncture seems superior to minimal electroacupuncture in the treatment of urgency-predominant.A solid conclusion cannot be drawn out of small sample sizes.The effectiveness of minimal electroacupuncture seems superior to solifenacin.Research c.BMI less than 27 and no or less complication tend to acquire effects immediately after 12-week treatment.Menopause,urinary incontinence episodes or micturition episodes do not influence the immediate effects of electroacupuncture after 12-week treatment on urgency-predominant MUI.The effectiveness of electroacupuncture for urgency-predominant MUI can sustained 24 weeks after cessation of treatment.Women with BMI less than 27 tend to maintained effectiveness;age,times of delivery,menopause,complications,frequency of leakage and urination had limited influence on the effects. |
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