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Study Title and Description

Pelvic static magnetic stimulation to control urinary incontinence in older women: 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 Pelvic static magnetic stimulation to control urinary incontinence in older women: a randomized controlled trial.
Author Wallis MC., Davies EA., Thalib L., Griffiths S.
Country Griffith University Research Centre for Clinical Practice Innovation, Queensland 4222, Australia. M.Wallis@griffith.edu.au
Year 2012
Numbers Pubmed ID: 21817123

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 magnetic stimulation
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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 Australia
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Funding source Explicitly not industry funded
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Inclusion criteria 60 or older, experience stress, urge, or MUI at least once a week for the past 6 months
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Exclusion criteria implanted electronic device, symptomatic UTI int eh past 4 weeks, pelvic surgery in the prior 3 months.
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UI type 36.6
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11.9
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51.5
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Age 70.1
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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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100
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all over age 60
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Race
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2004-2005
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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 magnetic stimulation placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 62 60 122
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50 51 101
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12 9 21
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (stress)      Population: All Participants Between-Arm Comparisons
Time Point Measure magnetic stimulation placebo Comparison Measure ERROR vs. ERROR


12 weeks

N Analyzed 50 51 Net P value 0.3
Median 5 3.5
IQR 5.25 4.25
Outcome: Leakage test: Pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure magnetic stimulation placebo Comparison Measure magnetic stimulation vs. placebo


12 weeks

N Analyzed 50 51 Net P value 0.4
Median 36 20
IQR 96.8 83.0


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 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.