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Study Title and Description

Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial.



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 Effect of electromyographic biofeedback as an add-on to pelvic floor muscle exercises on neuromuscular outcomes and quality of life in postmenopausal women with stress urinary incontinence: A randomized controlled trial.
Author Bertotto A., Schvartzman R., Uchôa S., Wender MCO.
Country Graduate Program in Medical Sciences, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.
Year 2017
Numbers Pubmed ID: 28508398

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Control
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2 PFME
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3 PFME + BF
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Brazil
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Funding source Not reported
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Inclusion criteria Postmenopausal status, age50-65 years, a complaint of loss of urine on exertion (detectedby the International Consultation on Incontinence Question-naire), and provision of written informed consent.
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Exclusion criteria Presence of a urinary tractinfection, failure to understand pelvic floor muscle contrac-tion, cognitive alterations, collagen- or muscle-relateddiseases, or neurological abnormalities.
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UI type
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100
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Directionality Prospective
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Age 58.3
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mean
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5.8
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Men included 0
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Special populations
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52
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100
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post-menopausal
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Race 52
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100
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Notes
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Did participants fail previous treatment? No (explicitly treatment naive)
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Study years 2014-2014
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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 Control PFME PFME + BF Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 16 16 17 49
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14 15 16 45
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2 1 1 4
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Quality of life      Population: All Participants
Time Point Measure Control PFME PFME + BF


0 weeks

N Analyzed 14 15 16
Mean 11.1 11.1 12.7
SD 4.5 2.9 3.6


4 weeks

N Analyzed 14 15 16
Mean 10 4.3 4.5
SD 4.8 3.2 3.6


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.