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Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial
- Source :
- JAMA. 317(24)
- Publication Year :
- 2017
-
Abstract
- Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited.To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI.Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015.Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints.The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes).Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild.Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention.clinicaltrials.gov Identifier: NCT01784172.
- Subjects :
- Adult
medicine.medical_specialty
China
Time Factors
Electroacupuncture
medicine.medical_treatment
Urinary Incontinence, Stress
Urinary incontinence
law.invention
Lumbosacral region
03 medical and health sciences
0302 clinical medicine
Urinary Leakage
Randomized controlled trial
law
Medicine
Humans
030212 general & internal medicine
Aged
business.industry
Incidence (epidemiology)
Incidence
Lumbosacral Region
General Medicine
Middle Aged
Surgery
Pad test
Treatment Outcome
030220 oncology & carcinogenesis
Skin penetration
Anesthesia
Female
medicine.symptom
business
Acupuncture Points
Subjects
Details
- ISSN :
- 15383598
- Volume :
- 317
- Issue :
- 24
- Database :
- OpenAIRE
- Journal :
- JAMA
- Accession number :
- edsair.doi.dedup.....9dabf075fbc4da7b8bd9d7d175806440