Browse > Article
http://dx.doi.org/10.15204/jkobgy.2018.31.1.084

Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women with Overactive Bladder; a Pilot Study of Randomized Clinical Controlled Trial  

Nam, Eun-Young (Dept of Korean Obstetrics & Gynecology, Dong-Incheon Gachon University Gil Korean Medicine Hospital)
Jung, Seung-Hyun (Dept. of Korean Internal Medicine, Bundang Dong-Guk University Korean Medicine Hospital)
Bae, In-Suk (Dept. of Korean Internal Medicine, Bundang Dong-Guk University Korean Medicine Hospital)
Choi, Su-Ji (Dept of Korean Medicine Obstetrics & Gynecology, Ilsan Dong-Guk University Korean Medicine Hospital)
Kim, Dong-Il (Dept of Korean Medicine Obstetrics & Gynecology, Ilsan Dong-Guk University Korean Medicine Hospital)
Publication Information
The Journal of Korean Obstetrics and Gynecology / v.31, no.1, 2018 , pp. 84-98 More about this Journal
Abstract
Objectives: The purpose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture and electroacupuncture in treating overactive bladder (OAB) in menopause women. We tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing OAB symptoms and improving disease-specific quality of life. We also tried to determine the appropriate treatment duration of OAB, with safety of performing acupuncture and electroacupuncture treatment. Methods: This study was a randomized clinical trial. 7 menopause women were randomly assigned to a electroacupuncture group (EA group) (n=4) or acupuncture group (AC group) (n=3) and received electroacupuncture or acupuncture treatment twice a week (16 sessions) in 8 weeks, and follow up assessment was performed after the end of treatment. Overactive Bladder Symptom Score (OABSS), 3-day bladder diary, and King's Health Questionnaire (KHQ) were performed 4 times (at baseline (visit 0), the middle of treatment (visit 8), after the end of treatment (visit 16), and at 4 weeks of follow-up (visit 17)) and analyzed. 2 subjects were dropped out, and finally 5 subjects completed the study. Statistical analysis was performed using SPSS 18.0 for window program. Results: There was an significant improvement in night-time frequency after the treatment (visit 17) in PP (Per-protocol) group analysis (p=0.042). In additional ITT (Inter-to-treat) group analysis, the OABSS (p=0.042) and night-time frequency (p=p=0.017) were improved significantly after the treatment (visit 17). But there was no significant difference of KHQ before and after the treatment. Also there was no significant difference between EA and AC group after the treatment (visit 16, 17). Conclusions: The results of this pilot study suggested that it was feasible to recruit subjects and perform the study procedures, after reconstructing several details of study protocol in performing further clinical trial.
Keywords
Overactive Bladder; Postmenopausal Women; Menopause; Acupuncture; Electroacupuncture;
Citations & Related Records
Times Cited By KSCI : 2  (Citation Analysis)
연도 인용수 순위
1 Homma Y, et al. Symptom assessment tool for overactive bladder syndrome-overactive bladder symptom score. Urology. 2006;68(2):318-23.   DOI
2 Kelleher CJ, Cardozo LD, Toozs-Hobson PM. Quality of life and urinary incontinence. Curr Opin Obstet Gynecol. 1995;7(5):404-8.
3 Kelleher CJ, et al. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997;104(12):1374-9.   DOI
4 Reese PR, et al. Multinational study of reliability and validity of the King's Health Questionnaire in patients with overactive bladder. Qual Life Res. 2003;12(4):427-42.   DOI
5 Oh SJ, et al. Psychometric properties of the Korean version of the King's Health Questionnaire in women with stress urinary incontinence. Journal of the Korean Continence Society. 2005;9(2):115-23.   DOI
6 Hertzog MA. Considerations in determining sample size for pilot studies. Research in nursing & health. 2008;31(2):180-91.   DOI
7 Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-91.   DOI
8 Oh SJ, et al. Translation and linguistic validation of Korean version of the King's Health Questionnaire instrument. Korean Journal of Urology. 2005;46(5):438-50.
9 Jonathan JS, Dmochowski RR. Urgency assessment in the evaluation of overactive bladder (OAB). Neurourology and Urodynamics. 2008;27(1):13-21.   DOI
10 Haylen BT, et al. An international urogynecological association(IUGA)/ international continence society(ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21(1):5-26.   DOI
11 Korean continence society. Textbook of voiding dysfunction and female urology. 3rd ed. Seoul:Ilchokak. 2004:102.
12 The society of Korean medicine obstetrics and gynecology. Korean medicine obstetrics and gynecology. Seoul:Uiseongdang. 2012:823-32, 834, 841, 844-50.
13 Lee YS, et al. Prevalence of overactive bladder, urinary incontinence, and lower urinary tract symptoms:results of Korean EPIC study. World J Urol. 2011;29(2):185-90.   DOI
14 Xu HR, Liu ZS, Zhao H. Systematic evaluation for treatment with acupuncture for overactive bladder syndrome. Xian Dai Zhong Xi Yi Jie He Za Zhi. 2011;20(4):393-9.
15 Homma Y, et al. Symptom assessment tool for overactive bladder syndrome -overactive bladder symptom score. Urology. 2006;68(2):318-23.   DOI
16 Choi MS, Kim DI. A Study on Korean Medical Clinical Management of Female Overactive Bladder. J Korean Obstet gynecol. 2014;27(2):83-102.   DOI
17 Jung SY, Kim DI. Retrospective study on overactive bladder. J Korean Obstet gynecol. 2009;22(3):169-84.
18 Yuelai C, et al. Experimental study on the effect of Electroacupuncture of "Huiyang" and "Zhonglushu" on Urodynamics in nonbacterial prostatitis rats. Acupuncture Research. 2001;26(2):127-30.
19 Wang XY, Zheng HT. Cai DF. Effects of Electroacupuncture of "Zhonglushu" on Experimental Hyperactivity of the Bladder in the Rat. Acupuncture Research. 2003;28(2):119-23.
20 Zhishun L, et al. Clinical Study on Electroacupuncture Treatment of Senile Imperative Urinary Incontinence [J]. Chinese Acuponcture & Moxibustion. 2001;21(10):579-82.
21 Irwin DE, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006;50:1306-14.   DOI
22 Stewart F, et al. Electrical stimulation with non-implanted electrodes for overactive bladder in adults. Cochrane Database of Systematic Reviews. 2016;12:CD010098.
23 Abrams, P, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. American journal of obstetrics and gynecology. 2002;187(1):116-26.   DOI
24 Kim SA, et al. The Relating Factor and Quality of Life of Overactive Bladder in Adults. Korean Journal of Family Medicine. 2009;30(11):872-9.   DOI
25 Yang SK. Psycho-urology: Possible links between stress, anxiety, depression, and bladder function. Journal of Korean Continence Society. 2006;10(1):1-8.   DOI
26 Kim MY, et al. Symptom bother, physical and mental stress, and healthrelated quality of life in women with overactive bladder syndrome. Korean Journal of Women Health Nursing. 2013;19(4):295-305.   DOI
27 Sang JH, Park HM. Survey on the prevalence of overactive bladder in healthy Korean postmenopausal women. The Journal of Korean Society of Menopause. 2012;18(1):60-6.   DOI
28 Haylen BT, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Journal of the Association of Chartered Physiotherapists in Women's Health.Spring 2012;110:33-57.
29 Dmochowski RR, et al. Bladderhealthdiaries: an assessment of 3-day vs 7-day entries. BJU Int. 2005;96(7):1049-54.   DOI
30 European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products. Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women. London:European Agency for the Evaluation of Medicinal Products. 2002:CPMP/EWP/18/01.
31 Wyndaele JJ, et al. Effect of flexible -dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009;63(4):560-7.   DOI