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.
Written by:
Su T, Zhou J, Liu Z, Chen Y, Zhang W, Chu H, Luo Q, Lu J, An J, Liu B. Are you the author?
Shaanxi Hospital of Traditional Chinese Medicine, Xi'an, Shaanxi, 710003, China; Shaanxi University of Traditional Chinese Medicine, Xianyang, Shaanxi, China; China Academy of Chinese Medical Sciences, Guang'anmen Hospital, Beijing, 100053, China; Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China; The First Hospital of Hunan University of Chinese Medicine, Hunan, 410208, China; Anhui Hospital of Acupuncture and Moxibustion, Anhui, 230031, China; Nanjing Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu, 210023, China; Xi'an hospital of Traditional Chinese Medicine, Xi'an, Shaanxi, 710003, China. ; ; ; ; ; ; ; ; ;
Reference: Trials. 2015 Feb 8;16(1):45.
doi: 10.1186/s13063-015-0560-1
PubMed Abstract
PMID: 25887231