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Study Title and Description

Comparison of the efficacy of perineal and intravaginal biofeedback assisted pelvic floor muscle exercises in women with urodynamic 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 Comparison of the efficacy of perineal and intravaginal biofeedback assisted pelvic floor muscle exercises in women with urodynamic stress urinary incontinence.
Author Özlü A., Yıldız N., Öztekin Ö.
Country Department of Physical Medicine and Rehabilitation, Pamukkale University Faculty of Medicine, Denizli, Turkey.
Year 2017
Numbers Pubmed ID: 28345778

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 home exercise
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2 home exercise + intravaginal biofeedback
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3 home exercise + perineal EMG biofeedback
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Turkey
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Funding source Explicitly not industry funded
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Inclusion criteria Women >= 18 with urodynamically confirmed diagnoses of SUI of mild to moderate severity. The strength of PFM 3/5 and more
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Exclusion criteria Pregnancy; Current vulvovaginitis or urinary tract infections or malignancy; Previous surgery for stress incontinence; Anatomic structural disorders of genitoanal region; Neurologic or psychiatric disease; Previous conservative therapy within 6 months; More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)17; Allergy to condom or lubricant gel that is used with perineometer/probe
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UI type
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100
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Age 42.4
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mean
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8.2
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Men included 0
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Special populations 51
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100
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Race 51
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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 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 home exercise home exercise + intravaginal biofeedback home exercise + perineal EMG biofeedback Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 18 17 18
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17 17 17
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1 0 1
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lack of compliance lack of compliance
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Quality of life      Population: All Participants
Time Point Measure home exercise home exercise + intravaginal biofeedback home exercise + perineal EMG biofeedback


8 weeks

N Analyzed
Counts
n no change
n satisfied
n not satisfied
P-Value
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure home exercise home exercise + intravaginal biofeedback home exercise + perineal EMG biofeedback Comparison Measure All Arms (ANOVA)


8 weeks

N Analyzed 17 17 17 0.033
Counts
n no change 9 3 3
n cured or improved 8 14 14
P-Value
Outcome: Satisfaction with intervention      Population: All Participants Between-Arm Comparisons
Time Point Measure home exercise home exercise + intravaginal biofeedback home exercise + perineal EMG biofeedback Comparison Measure All Arms (ANOVA)


8 weeks

N Analyzed 17 17 17 0.033
Counts
n no change 8 4 1
n satisfied 7 13 15
n not satisfied 2 0 1


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear RoB not reported
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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") 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.