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Study Title and Description

Randomized controlled trial of physiotherapy for postpartum stress incontinence: 7-year follow-up.



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 Randomized controlled trial of physiotherapy for postpartum stress incontinence: 7-year follow-up.
Author Dumoulin C., Martin C., Elliott V., Bourbonnais D., Morin M., Lemieux MC., Gauthier R.
Country Faculty of Medicine, School of Rehabilitation, University of Montreal, Montreal, Québec, Canada. chantal.dumoulin@umontreal.ca
Year 2013
Numbers Pubmed ID: 23554139

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 PFMT
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2 PFMT + TrA
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Canada
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Funding source Explicitly not industry funded
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Inclusion criteria SUI symptoms as defined by the International Continence Society: one urinary incontinence episode at least once a week, 3 months or more after their last delivery
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Exclusion criteria SUI onset prior to pregnancy or delivery, previous surgery for SUI, a neurological or psychiatric disease or a major medical condition, or took medication that could interfere with their evaluation or treatment.
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UI type
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100
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one urinary incontinence episode at least once a week, 3 months or more after their last delivery
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Age 36
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medan
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nd
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33-39
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Men included 0
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Special populations 57
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100
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Race 57
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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 2001-2002
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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 PFMT PFMT + TrA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 28 29 57
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18 17 35
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10 12 22
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Leakage test: Pad test      Population: All Participants Between-Arm Comparisons
Time Point Measure PFMT PFMT + TrA Comparison Measure PFMT vs. PFMT + TrA


7 years

N Analyzed 18 17 P-Value 0.82
Median 2.50 2.00
Q1 0.25 1.00
Q3 17.25 6.00


3 months

N Analyzed 18 17 P-Value 0.82
Median 13.00 10.00
Q1 7.00 6.00
Q3 34.00 48.00
Outcome: Urgency bother by VAS (0–100)      Population: All Participants Between-Arm Comparisons
Time Point Measure PFMT PFMT + TrA Comparison Measure PFMT vs. PFMT + TrA


7 years

N Analyzed 18 17 P-Value 0.13
Median 5.50 3.00
Q1 3.75 1.00
Q3 7.00 7.00


3 months

N Analyzed 18 17 P-Value 0.16
Median 8.00 7.00
Q1 6.75 4.50
Q3 8.00 8.00
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure PFMT PFMT + TrA Comparison Measure PFMT vs. PFMT + TrA


7 years

N Analyzed 18 17 P-Value 0.10
Median 9.00 7.00
Q1 6.75 2.00
Q3 15.50 12.50


3 months

N Analyzed 18 17 P-Value 0.18
Median 12.00 10.00
Q1 10.00 6.50
Q3 13.25 13.50
Outcome: Incontinence Severity Index      Population: All Participants Between-Arm Comparisons
Time Point Measure PFMT PFMT + TrA Comparison Measure PFMT vs. PFMT + TrA


3 months

N Analyzed 18 17 P-Value 0.03
Median 26.00 14.00
Q1 16.75 3.00
Q3 14.00 28.00




N Analyzed P-Value
Median
Q1
Q3


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment High RoB
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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") 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
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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.