title: A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence.
abstract: BACKGROUND
  Acupuncture is a potential conservative therapy for women with stress urinary incontinence (SUI). There is limited evidence to support its effectiveness due to the poor quality of existing studies.
  
  
  METHODS
  We performed a pilot randomized, controlled trial to preliminarily assess the efficacy of electroacupuncture (EA) in women with pure SUI. A total of 80 women with pure SUI were randomly assigned to receive EA with deep needling at BL33 and BL35 (n = 40) or sham EA with non-penetrating needling at sham acupoints (n = 40) three sessions per week for 6 weeks. The women were followed for 24 weeks. The primary outcome was the change from baseline in the amount of urine leakage measured by a 1-hour pad test after 6 weeks. The secondary outcomes included the 72-hour incontinence episode frequency (IEF), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, and patient self-evaluation of therapeutic effect. Adverse events (AEs) were monitored throughout the trial.
  
  
  RESULTS
  The median decrease from baseline of urine leakage measured by the 1-hour pad test was 2.5 g [interquartile range (IQR): 1.80-14.6 in the EA group, which was greater than the median decrease of 0.05 g (IQR: -2.80-+0.50) in the sham EA group after 6 weeks (p<0.01). The differences between groups in the decrease from baseline of 72-hour IEF became statistically significant at week 30 with a median decrease of 3.25 g (IQR: 1.25-5.69) in the EA group, and a median decrease of 1.00 g (IQR: -0.69-+2.88) in the sham EA group (p = 0.01). The participants in the EA group showed greater decreases in ICIQ-SF score and higher ratings in the help they received from the treatment than those in the sham EA group at weeks 6,18 and 30 (all p<0.05). No obvious AEs were observed in either group.
  
  
  CONCLUSIONS
  EA may effectively and safely relieve urinary incontinence symptoms and improve quality of life in women with pure SUI. EA demonstrated more than a placebo effect. Since this is a pilot study, results should be interpreted with caution.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02445573.
authors.affiliation: Department of acupuncture and moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Huanfang
authors.initials: H
authors.lastname: Xu
authors.affiliation: Department of acupuncture and moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Baoyan
authors.initials: B
authors.lastname: Liu
authors.affiliation: Department of acupuncture and moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Jiani
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of acupuncture and moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Ruosang
authors.initials: R
authors.lastname: Du
authors.affiliation: Department of acupuncture and moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.|School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
authors.forename: Xiaoxu
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of acupuncture and moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Jinna
authors.initials: J
authors.lastname: Yu
authors.affiliation: Department of acupuncture and moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Zhishun
authors.initials: Z
authors.lastname: Liu
mesh_terms: D003710:Demography; D015671:Electroacupuncture / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D015990:Placebo Effect; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000628:therapy*