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Study Title and Description

The effects of multidimensional exercise treatment on community-dwelling elderly Japanese women with stress, urge, and mixed urinary incontinence: 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 The effects of multidimensional exercise treatment on community-dwelling elderly Japanese women with stress, urge, and mixed urinary incontinence: a randomized controlled trial.
Author Kim H., Yoshida H., Suzuki T.
Country Research Team for Promoting Independence of the Elderly, Tokyo Metropolitan Institute of Gerontology, Japan. kimhk@tmig.or.jp
Year 2011
Numbers Pubmed ID: 21459381

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 pelvic floor muscle exercises
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2 control
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Japan
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Funding source Explicitly not industry funded
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Inclusion criteria >= 70 years old; having urine leakage episodes more than once a week
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Exclusion criteria impaired cognition, unstable cardiac conditions or other musculoskeletal conditions.
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UI type 37
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29
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34
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Age 76
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mean
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4.4
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Men included 0
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Special populations
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127
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100
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>70
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Race 127
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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 2006-
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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 pelvic floor muscle exercises control Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 63 64 127
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59 61 120
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4 3 7
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1 hip fracture, 1 moved away, 1 knee pain, 1 spouse care 1 died, 1 hospitalized, decreased motivation
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Notes No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure pelvic floor muscle exercises control Comparison Measure pelvic floor muscle exercises vs. control


7 months

N Analyzed 59 61 <0.001
Counts 23 1
Percentage 39.3 1.6
Outcome: Cure etc.      Population: stress
Time Point Measure pelvic floor muscle exercises control


7 months

N Analyzed 19
Counts 13
Percentage 66.7
Outcome: Cure etc.      Population: urge
Time Point Measure pelvic floor muscle exercises control


7 months

N Analyzed 22
Counts 6
Percentage 26.1
Outcome: Cure etc.      Population: mixed
Time Point Measure pelvic floor muscle exercises control


7 months

N Analyzed 22
Counts 7
Percentage 30
Net P value
Outcome: Incontinence count/frequency (total)      Population: All Participants Between-Arm Comparisons
Time Point Measure pelvic floor muscle exercises control Comparison Measure All Arms (ANOVA)


0 months

N Analyzed 59 61
Mean 5.0 5.1
SD 1.0 1.0
SE


7 months

N Analyzed 59 61 0.007
Mean 3.6 4.8
SD 2.2 1.6
SE


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 High RoB 2 drop outs in the intervention arm were potentially treatment related
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ALL.....Blinding of OUTCOME ASSESSORS (or "DOUBLE BLIND") High 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 mean attendance at classes = 70%
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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.