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Study Title and Description

Safety and Efficacy Study of a New Treatment for Symptoms of Urinary 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 Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence
Author McMichael J
Country
Year 2013
Numbers

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 tolterodine
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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 U.S.
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Funding source Industry funded/industry provided materials
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Inclusion criteria Women who have moderate to severe urge, stress or mixed Urinary Incontinence
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Exclusion criteria History of migraines, neurologic problems, swallowing disorder, stroke, severe depression, heart failure, peripheral edema, moderate to severe asthma, chronic obstructive pulmonary disease
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UI type 100
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Age 54.4
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mean
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22, 92
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Men included 0
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Special populations 67
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100
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Race 67
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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 2011-2012
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Trial name (if given) REMOTE
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question tolterodine placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 67
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67
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0
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Notes patient flow from record
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Results & Comparisons


Results Data
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure tolterodine placebo Comparison Measure tolterodine vs. placebo


4 weeks

N Analyzed 34 33 P-Value 0.92
Counts 21 20


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear RoB not reported
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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) Unclear RoB very few baselines given
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ALL.....Compliance with interventions Unclear RoB not reported
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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? No dosage not given in mg
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Quality Rating
No quality rating data was found.