Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol

BMC Complementary and Alternative Medicine

Study Protocol

Baoyan Liu¹  Zhishun Liu¹  Huanfang Xu¹  Yang Wang¹  Jiani Wu¹  Qian Mo¹  Yuelai Chen² 

[1] Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No.5 Beixiange Street, Beijing, Xicheng District, China;Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Shanghai, Pudong, China;

关键词: Electroacupuncture;    Pelvic floor muscle training;    Solifenacin;    Mixed urinary incontinence;   

DOI  :  10.1186/1472-6882-14-301

 received in 2014-04-21, accepted in 2014-08-11,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundIn women with mixed urinary incontinence, pelvic floor muscle training and solifenacin is the recommended conservative treatment, while electroacupuncture is a safe, economical and effective option.Methods/DesignIn this prospective, multi-center, randomized controlled trial, five hundred women with mixed urinary incontinence, from 10 centers will be randomized to receive either electroacupuncture or pelvic floor muscle training plus solifenacin. Women in the acupuncture group will receive electroacupuncture for 3 sessions per week, over 12 weeks, while women in the control group will receive pelvic floor muscle training plus solifenacin (5 mg once daily) for 36 weeks. The primary outcome measure is the proportion of change in 72-hour incontinence episode frequency from baseline to week 12. The secondary outcome measures include eleven items, including proportion of participants with ≥50% decrease in average 72-h incontinence episode frequency, change from baseline in the amount of urine leakage and proportion of change from baseline in 72-h incontinence episode frequency in week 25–36, and so forth. Statistical analysis will include covariance analysis, nonparametric tests and t tests.DiscussionThe objective of this trial is to compare the efficacy and safety of electroacupuncture versus pelvic floor muscle training plus solifenacin in women with moderate and severe mixed urinary incontinence.Trial registrationClinicalTrials.gov Identifier: NCT02047032

【 授权许可】

CC BY   
© Liu et al.; licensee BioMed Central Ltd. 2014