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Study Title and Description

Long-term results of a clinical trial comparing isolated vaginal stimulation with combined treatment for women with 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 Long-term results of a clinical trial comparing isolated vaginal stimulation with combined treatment for women with stress incontinence.
Author Fürst MC., Mendonça RR., Rodrigues AO., Matos LL., Pompeo AC., Bezerra CA.
Country Faculdade de Medicina do ABC, Santo André, SP, Brazil.
Year 2014
Numbers Pubmed ID: 25003921

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 vaginal electrical stimulation
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2 vaginal electrical stimulation + pelvic floor muscle training
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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 clinical and urodynamic SUI
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Exclusion criteria none listed
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UI type 62.9
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100
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62.9
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Age 49.6
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mean
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10.6
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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? ... Yes ... Patients with a history of surgical treatment for SUI, pelvic reconstruction and hysterectomy were included
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Study years 2000-2002
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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 vaginal electrical stimulation vaginal electrical stimulation + pelvic floor muscle training Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 24 24 48
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17 18 35
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7 6 13
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Satisfaction with intervention      Population: All Participants
Time Point Measure vaginal electrical stimulation vaginal electrical stimulation + pelvic floor muscle training


3 months

N Analyzed 24 24
Counts 21 21


96 months

N Analyzed 24 24
Counts 10 7


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 Unclear 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.