Use the Back button in your browser to see the other results of your search or to select another record.

Detailed Search Results

A pilot randomized placebo controlled trial of electroacupuncture for women with pure stress urinary incontinence
Xu H, Liu B, Wu J, Du R, Liu X, Yu J, Liu Z
PLoS ONE 2016 Mar;11(3):e0150821
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 14.6) in the EA group, which was greater than the median decrease of 0.05 g (IQR -2.80 to +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 to 5.69) in the EA group, and a median decrease of 1.00 g (IQR -0.69 to +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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02445573.

Full text (sometimes free) may be available at these link(s):      help