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Study Title and Description

A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence.



Key Questions Addressed
1 KQ 1: What are the benefits and harms of nonpharmacological treatments of UI in women, and how do they compare with each other? KQ 2: What are the benefits and harms of pharmacological treatments of UI in women, and how do they compare with each other? KQ 3: What are the comparative benefits and harms of nonpharmacological versus pharmacological treatments of UI in women? KQ 4: What are the benefits and harms of combined nonpharmacological and pharmacological treatment of UI in women?
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Primary Publication Information
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TitleData
Title A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence.
Author Xu H., Liu B., Wu J., Du R., Liu X., Yu J., Liu Z.
Country Department of acupuncture and moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Year 2016
Numbers Pubmed ID: 26960195

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: All studies
Arms
Number Title Description Comments
1 electroacupuncture
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2 sham electroacupuncture
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries China
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Funding source Explicitly not industry funded
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Inclusion criteria Eligible women were aged 40 to 75 years, and met diagnosis of SUI by the International Consultation on Urological Diseases
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Exclusion criteria other type of UI; symptomatic urinary tract infection; ever received UI or pelvic surgery; severe pelvic organ prolapse; residual urinary volume >30 ml; maximum flow rate  20 ml/s; limited in walking, stairs climbing and running; receiving specialized treatment for SUI or use of medicine affecting bladder function; serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, multiple system atrophy, injury of cauda equina, or myeleterosis; pregnant or breastfeeding; with cardiac pacemaker, metal allergy or severe needle phobia
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UI type
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100
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Age 58.5
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mean
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8.2
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Men included 0
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Special populations 80
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100
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Race 80
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100
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Notes
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Did participants fail previous treatment? ... Yes ... 10 Ever received SUI treatment
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Study years 2012-2014
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Trial name (if given)
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question electroacupuncture sham electroacupuncture Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 40 40 80
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39 38 77
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1 2 3
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not satisfied with tx, withdrew 1 not satisfied with tx, 1 left (job change)
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Satisfaction with intervention      Population: All Participants
Time Point Measure electroacupuncture sham electroacupuncture


6 weeks

N Analyzed 40 40
Counts
n very much better 27 9
n much better 8 3
n a little better 4 11
n no change 1 17
Outcome: Leakage test: Pad test      Population: All Participants
Time Point Measure electroacupuncture sham electroacupuncture


0 weeks

N Analyzed
Mean
SD
SE


6 weeks

N Analyzed
Mean
SD
SE


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Low RoB
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RCT:.....Blinding of PATIENTS Low RoB
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RCT.....Intention-to-treat-analysis Low RoB
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Low RoB
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ALL.....Incomplete results data (attrition bias) Low RoB
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ALL....Group similarity at baseline (selection bias) Low RoB
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ALL.....Compliance with interventions Low RoB
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NRCS.....Patients in different intervention groups selected in an equivalent manner
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)?
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ALL.....Other issues
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.