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Study Title and Description

Effect the adding of biofeedback to the training of the pelvic floor muscles to treatment of 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 Effect the adding of biofeedback to the training of the pelvic floor muscles to treatment of stress urinary incontinence.
Author Fitz FF., Resende AP., Stüpp L., Costa TF., Sartori MG., Girão MJ., Castro RA.
Country Departamento de Ginecologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brasil.
Year 2012
Numbers Pubmed ID: 23288261

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Control Group
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2 Biofeedback Group
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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 SUI without sphincter deficiency, detected by urodynamic study and who could performed the correct PFM contraction.
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Exclusion criteria Women with neuromuscular disorders and grade III and IV genital prolapse were excluded. Hormonal therapy
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UI type
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100
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Age 58.1
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mean
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9.3
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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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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2009-2010
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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 Group Biofeedback Group Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 19 18 37
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16 16 32
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3 2 5
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Quality of life      Population: All Participants
Time Point Measure Control Group Biofeedback Group


0 weeks

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6 weeks

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Outcome: Incontinence count/frequency (stress)      Population: All Participants
Time Point Measure Control Group Biofeedback Group


0 weeks

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Mean
SD
SE


6 weeks

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SD
SE


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear RoB
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RCT:.....Blinding of PATIENTS Unclear RoB
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RCT.....Intention-to-treat-analysis Low RoB 3/40 drop-outs
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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 Unclear 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
Guideline Used Overall Rating