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Study Title and Description

Transvaginal electrical stimulation with surface-EMG biofeedback in managing stress urinary incontinence in women of premenopausal age: a double-blind, placebo-controlled, randomized clinical 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 Transvaginal electrical stimulation with surface-EMG biofeedback in managing stress urinary incontinence in women of premenopausal age: a double-blind, placebo-controlled, randomized clinical trial.
Author Terlikowski R., Dobrzycka B., Kinalski M., Kuryliszyn-Moskal A., Terlikowski SJ.
Country Department of Rehabilitation, Medical University of Bialystok, Bialystok, Poland.
Year 2013
Numbers Pubmed ID: 23443345

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 transvaginal electrical stimulation with surface-electromyography-assisted biofeed- back
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2 placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries poland
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Funding source Not reported
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Inclusion criteria
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Exclusion criteria exclusion factors were patients with chronic de- generative diseases that would affect muscular and nerve tissues, presence of any degree of pelvic organ prolapse (POP), active or recurrent urinary tract infections (UTI), vulvovaginitis, atrophic vaginitis, diabetes mellitus, neuro- logical disease, psychiatric illness, use of medication affect- ing micturition, history of surgical or pharmaceutical treatment of SUI, chronic debilitating disease such as renal failure, and those with cardiac pacemakers. We also exclud- ed patients with intrinsic sphincteric deficiencies identified by the Valsalva leak-point pressure ≤60 cmH20 measure- ment in the sitting position with a volume of 250 ml in the bladder and/or a urethral closure pressure ≤20 cmH20 in the sitting position at maximum cystometric capacity.
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UI type
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100
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urodynamic SUI
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Age 46.9
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mean
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6.8
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Men included 0
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Special populations
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Race 100
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Notes
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Did participants fail previous treatment? ... Some ... they could not have had prior pharmacologic or surgical treatment for SUI
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Study years 2008-2012
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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 transvaginal electrical stimulation with surface-electromyography-assisted biofeed- back placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 68 34 102
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64 29 93
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4 5 9
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants
Time Point Measure transvaginal electrical stimulation with surface-electromyography-assisted biofeed- back placebo


16 weeks

Percentage 39 0
Counts 25 0
Outcome: Cure etc.      Population: All Participants
Time Point Measure transvaginal electrical stimulation with surface-electromyography-assisted biofeed- back placebo


16 weeks

Percentage 45.3 6.9
Counts 29 2
Outcome: Cure etc.      Population: All Participants
Time Point Measure transvaginal electrical stimulation with surface-electromyography-assisted biofeed- back placebo


16 weeks

Counts 12 4
N Analyzed 64 29


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 No
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.