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Study Title and Description

Efficacy and safety of oxybutynin chloride topical gel for women with overactive bladder syndrome.



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 Efficacy and safety of oxybutynin chloride topical gel for women with overactive bladder syndrome.
Author Sand PK., Davila GW., Lucente VR., Thomas H., Caramelli KE., Hoel G.
Country Evanston Continence Center, NorthShore University HealthSystem, and University of Chicago Pritzker School of Medicine, Chicago, IL 60637, USA. peterksand@gmail.com
Year 2012
Numbers Pubmed ID: 21963104

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 oxybutynin cholide topical gel
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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 United States of America
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Funding source Industry funded/industry provided materials
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Inclusion criteria 18 years of age or older, female, 8 or more urinary and 4 or more urge incontinence episodes per day, non-pregnant, non-lactating
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Exclusion criteria treatable conditions that may cause urinary incontinence, medical conditions in which it would be unsafe to use an anti-cholinergic agent, use of concomitant drugs that would confound the efficacy evaluation, use of concomitant drugs that would be unsafe with anti-cholinergic agents.
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UI type 100
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Age 59.1
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mean
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12.3
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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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610
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86.6
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77
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10.9
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0
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0
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10
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1.4
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7
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0.9
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2006-2007
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Trial name (if given)
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Does this paper cite a previous paper from the same study? yes
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Baseline Characteristics
Question oxybutynin cholide topical gel Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 352 352 704
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352 352 704
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37 38 75
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Notes drop outs included in analysis drop outs included in analysis drop outs included in analysis
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Results & Comparisons


Results Data
P-Value
Outcome: Incontinence count/frequency (total)      Population: All Participants Between-Arm Comparisons
Time Point Measure oxybutynin cholide topical gel Placebo Comparison Measure ERROR vs. ERROR


Enter a numeric value or title (required) years

N Analyzed 352 352 .7575
Mean 5.4 5.5
SD 3.2 3.3


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 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 Unclear RoB outpatient treatment, adherence unclear.
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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 Yes industry funded
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.