Jing Kang1, Yuanjie Sun2, Tongsheng Su3, Yan Liu4, Fengxia Liang5, Zhishun Liu6. 1. Acupuncture and Moxibustion College, Hubei University of Chinese Medicine, Wuhan, 430061, China. 2. Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. 3. Shanxi Province Hospital of Traditional Chinese Medicine, Xi'an, 710003, China. 4. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China. 5. Acupuncture and Moxibustion College, Hubei University of Chinese Medicine, Wuhan, 430061, China. 315938821@qq.com. 6. Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. zhishunjournal@163.com.
Abstract
INTRODUCTION AND HYPOTHESIS: The aim was to investigate the effectiveness and safety of electroacupuncture (EA) in women with balanced mixed urinary incontinence (MUI) compared with PFMT plus solifenacin. METHODS: This is a secondary analysis of a randomized non-inferiority clinical trial. Seventy-nine patients with balanced MUI were randomly assigned to receive either 12-week EA with 24-week follow-up or 36-week PFMT and solifenacin. Primary outcome was the proportion of participants with ≥50% reduction of mean 24-h incontinence episode frequency (IFE) through weeks 1-12 from baseline. Analysis was performed in an intention-to-treat population using a generalized linear model with a binomial distribution, adjusted for imbalances in baseline variables, and a two-sided p value of less than 0.05 was considered significant. RESULTS: A total of 34 participants in the EA group and 45 participants in thePFMT plus solifenacin group were included in the intention-to-treat analysis of primary outcome. Through weeks 1-12, the proportion of participants with ≥50% reduction of mean 24-h IEF was 32.4% in the EA group, and 37.2% in the PFMT plus solifenacin group, with a mean difference of -2.82% (95%CI: -23.88 to 18.23, p=0.79), revealing non-inferiority. No significant difference held true for all the secondary outcomes. Six adverse events occurred in the EA group and 22 in the PEMT plus solifenacin group. CONCLUSIONS: The effect of EA is similar to PFMT plus solifenacin in relieving the symptoms of both SUI and UUI and increasing participants' quality of life but with better safety. The effects of EA may sustain 24 weeks after treatment.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The aim was to investigate the effectiveness and safety of electroacupuncture (EA) in women with balanced mixed urinary incontinence (MUI) compared with PFMT plus solifenacin. METHODS: This is a secondary analysis of a randomized non-inferiority clinical trial. Seventy-nine patients with balanced MUI were randomly assigned to receive either 12-week EA with 24-week follow-up or 36-week PFMT and solifenacin. Primary outcome was the proportion of participants with ≥50% reduction of mean 24-h incontinence episode frequency (IFE) through weeks 1-12 from baseline. Analysis was performed in an intention-to-treat population using a generalized linear model with a binomial distribution, adjusted for imbalances in baseline variables, and a two-sided p value of less than 0.05 was considered significant. RESULTS: A total of 34 participants in the EA group and 45 participants in the PFMT plus solifenacin group were included in the intention-to-treat analysis of primary outcome. Through weeks 1-12, the proportion of participants with ≥50% reduction of mean 24-h IEF was 32.4% in the EA group, and 37.2% in the PFMT plus solifenacin group, with a mean difference of -2.82% (95%CI: -23.88 to 18.23, p=0.79), revealing non-inferiority. No significant difference held true for all the secondary outcomes. Six adverse events occurred in the EA group and 22 in the PEMT plus solifenacin group. CONCLUSIONS: The effect of EA is similar to PFMT plus solifenacin in relieving the symptoms of both SUI and UUI and increasing participants' quality of life but with better safety. The effects of EA may sustain 24 weeks after treatment.
Authors: Holly E Richter; Heather J Litman; Emily S Lukacz; Larry T Sirls; Leslie Rickey; Peggy Norton; Gary E Lemack; Stephen Kraus; Pamela Moalli; Mary Pat Fitzgerald; Kimberly J Dandreo; Liyuan Huang; John W Kusek Journal: Obstet Gynecol Date: 2011-04 Impact factor: 7.661
Authors: Alfred E Bent; Angelo E Gousse; Susan L Hendrix; Carl G Klutke; Ash K Monga; Chui Kin Yuen; Eric S Meadows; Ilker Yalcin; David Muram Journal: Obstet Gynecol Date: 2005-10 Impact factor: 7.661
Authors: Bernard T Haylen; Dirk de Ridder; Robert M Freeman; Steven E Swift; Bary Berghmans; Joseph Lee; Ash Monga; Eckhard Petri; Diaa E Rizk; Peter K Sand; Gabriel N Schaer Journal: Neurourol Urodyn Date: 2010 Impact factor: 2.696