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Study Title and Description

Efficacy of Electrical Pudendal Nerve Stimulation in Treating Female Stress 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 Efficacy of Electrical Pudendal Nerve Stimulation in Treating Female Stress Incontinence.
Author Wang S., Lv J., Feng X., Wang G., Lv T.
Country Clinical Research Section, Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China; Yueyang Hospital of Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China. Electronic address: wangsiyou1234@163.com.
Year 2016
Numbers Pubmed ID: 26921645

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Electrical pudendal nerve stimulation
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2 electromyogram biofeedback assisted pelvic floor muscle training, + transvaginal electrical stimulation
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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 SUI history, positive stress test, urodynamically confirmed SUI, post void residual <50cc
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Exclusion criteria UUI, MUI ,neurogenic bladder
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UI type 0
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100
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0
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Age 56.9
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mean
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11.4
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Men included 0
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Special populations
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100
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Race
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100
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from China, would assume 100% Asian
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2013-2013
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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 Electrical pudendal nerve stimulation electromyogram biofeedback assisted pelvic floor muscle training, + transvaginal electrical stimulation Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 21 21 42
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21 21 42
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0 0 0
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure Electrical pudendal nerve stimulation electromyogram biofeedback assisted pelvic floor muscle training, + transvaginal electrical stimulation Comparison Measure Electrical pudendal nerve stimulation vs. electromyogram biofeedback assisted pelvic floor muscle training, + transvaginal electrical stimulation


4 months

N Analyzed 21 21 P-Value <0.01
n cured 11 3
Marked improvement 2 1
n improved 5 2
Outcome: Cure etc.      Population: All Participants
Time Point Measure Electrical pudendal nerve stimulation electromyogram biofeedback assisted pelvic floor muscle training, + transvaginal electrical stimulation


3 weeks

N Analyzed 80 40
Counts 56 18


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Unclear RoB
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RCT:.....Allocation concealment Unclear RoB
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RCT:.....Blinding of PATIENTS High RoB
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RCT.....Intention-to-treat-analysis Low RoB
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") Unclear 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 No
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.