The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial

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• 作者：Tongsheng Su (1)
  Jing Zhou (1) (2)
  Zhishun Liu (3)
  Yuelai Chen (4)
  Wei Zhang (5)
  Haoran Chu (6)
  Qiong Luo (1)
  Jin Lu (7)
  Junming An (8)
  Baoyan Liu (3)
  
  1. Shaanxi Hospital of Traditional Chinese Medicine ; Xi鈥檃n ; Shaanxi ; 710003 ; China
  2. Shaanxi University of Traditional Chinese Medicine ; Xianyang ; Shaanxi ; China
  3. China Academy of Chinese Medical Sciences ; Guang鈥檃nmen Hospital ; Beijing ; 100053 ; China
  4. Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine ; Shanghai ; 200437 ; China
  5. The First Hospital of Hunan University of Chinese Medicine ; Hunan ; 410208 ; China
  6. Anhui Hospital of Acupuncture and Moxibustion ; Anhui ; 230031 ; China
  7. Nanjing Hospital of Traditional Chinese Medicine ; Nanjing ; Jiangsu ; 210023 ; China
  8. Xi鈥檃n hospital of Traditional Chinese Medicine ; Xi鈥檃n ; Shaanxi ; 710003 ; China
  
• 关键词：Electroacupuncture ; Female stress urinary incontinence ; Pelvic floor muscle training
• 刊名：Trials
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：16
• 期：1
• 全文大小：406 KB
• 参考文献：1. Chen, YH, Lin, YN, Chen, WC, Hsieh, WT, Chen, HY (2014) Treatment of stress urinary incontinence by ginsenoside Rh2. Am J Chin Med. 42: pp. 817-31 CrossRef
  2. Kinchen, KS, Lee, J, Fireman, B, Hunkeler, E, Nehemiah, JL, Curtice, TG (2007) The prevalence, burden, and treatment of urinary incontinence among women in a managed care plan. J Womens Health. 16: pp. 415-22 CrossRef
  3. Minassian, VA, Drutz, HP, Al-Badr, A (2003) Urinary incontinence as a worldwide problem. Int J Gynecol Obstet. 82: pp. 327-38 CrossRef
  4. Yang, HJY (2000) Incidence of urinary incontinence survey in Beijing. Beijing J Med. 32: pp. 74-5
  5. Sand, PK, Owens, GM, Black, EJ, Anderson, LH, Martinson, MS (2014) Cost effectiveness of radiofrequency microremodeling for stress urinary incontinence. Int Urogynecol J. 4: pp. 517-23 CrossRef
  6. Chong, EC, Khan, AA, Anger, JT (2011) The financial burden of stress urinary incontinence among women in the United States. Curr Urol Rep. 12: pp. 358-62 CrossRef
  7. Wood, LN, Anger, JT (2014) Urinary incontinence in women. BMJ. 15: pp. 349
  8. B酶, K (2012) Pelvic floor muscle training in treatment of female stress urinary incontinence, pelvic organ prolapse and sexual dysfunction. World J Urol. 30: pp. 437-43 CrossRef
  9. Zhilan, Y, Jianping, S, Zihong, S (2011) Influence factors of compliance of older women in countryside with stress urinary incontinence using pelvic floor muscle exercise treatment. Chin Gerontol J. 31: pp. 2547-8
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  11. Mo, Q, Liu, Z (2013) Analysis of female stress urinary incontinence with treatment of acupuncture and moxibustion. Shang Hai J Acupunct Moxibustion 12: pp. 12-20
  12. Wang, Y, Zhisun, L, Peng, W, Zhao, J, Liu, B (2013) Acupuncture for stress urinary incontinence in adults. Cochrane Database Syst Rev. 1: pp. CD009408
  13. Idanpaan-Heikkila, JE (2001) Ethical principles for the guidance of physicians in medical research - the Declaration of Helsinki. Bull World Health Organ. 79: pp. 279
  14. Incontinence Severity Index (ISI). [https://www.christianacare.org/documents/urogynecology/Incontinence-Severity-Index.pdf]
  15. Roza, T, Araujo, MP, Viana, R, Viana, S, Jorge, RN, B酶, K (2012) Pelvic floor muscle training to improve urinary incontinence in young, nulliparous sport students: a pilot study. Int Urogynecol J. 23: pp. 1069-73 CrossRef
  16. Zhu, L, Lang, J, Li, C (2003) Development of nonsurgical methods. Chin J Obstetric Gynecol. 38: pp. 318-9
  17. Zhou, Q, Gao, W (2010) 20 Cases of female stress urinary incontinence patients with electroacupuncture. J Acupunct Moxibustion. 22: pp. 21-6
  18. Mo, Q, Liu, Z, Ma, X (2013) Effective observation on stress urinary incontinence with electroacupuncture therapy. Beijing J Tradit Chin Med. 20: pp. 434-6
  19. Dumoulin, C, Glazener, C, Jenkins, D (2011) Determining the optimal pelvic floor muscle training regimen for women with stress urinary incontinence. Neurourol Urodyn. 3: pp. 746-53 CrossRef
  20. Sandvik, H, Seim, A, Vanvik, A, Hunskaar, S (2000) A severity index for epidemiological surveys of female urinary incontinence: comparison with 48-hour pad-weighing tests. Neurourol Urodyn. 19: pp. 137-45 CrossRef
  
• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Previous research has shown that electroacupuncture therapy has a potential therapeutic effect for simple female stress urinary incontinence. In this study, pelvic floor muscle training, the first-line treatment for stress urinary incontinence in women based on meta-analysis of numerous randomized control trials and recommended by international clinical practice, is used as a control group to demonstrate whether electroacupuncture therapy is a better method for female stress urinary incontinence. Methods/design A randomized controlled trial has been designed to evaluate the therapeutic benefit of electroacupuncture for female stress urinary incontinence compared with pelvic floor muscle training. The safety of electroacupuncture and patient compliance will also be evaluated. Untoward reaction to the electroacupuncture, including a broken needle, fainting on acupuncture, or pain during acupuncture, will be recorded and the therapy will be stopped if an untoward reaction occurs. After we have received full ethical approval and patient consent, participants will be randomized to receive a series of 24 electroacupuncture or pelvic floor muscle training interventions. The frequency and amount of leakage will be measured as the primary outcome parameters. Secondary outcome parameters include the 1-hour pad test, the short-form of the International Consultation on Incontinence Questionnaire, patient subjective effectiveness evaluation, weekly usage of pad, and usage of specialty therapy for female stress urinary incontinence. Discussion This trial will help to determine whether electroacupuncture is a more effective treatment than pelvic floor muscle training for patients with female stress urinary incontinence. Trial registration ClinicalTrials.gov NCT01940432 (12 September 2013).