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Study Title and Description

Efficacy of Botulinum Toxin A Intradetrusor Injections for Non-neurogenic Urinary UrgE Incontinence: A Randomized Double-Blind 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 Efficacy of Botulinum Toxin A Intradetrusor Injections for Non-neurogenic Urinary UrgE Incontinence: A Randomized Double-Blind Controlled Trial
Author Jabs, C, Carleton, E
Country
Year 2013
Numbers Pubmed ID: 23343798

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Placebo once
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2 Botulinum toxin
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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 Females over 18 years of age Diagnosis of urinary urge incontinence with resistance to or intolerance of anticholinergic medication Willingness and ability to use self-catheterization if necessary
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Exclusion criteria Urinary urge incontinence secondary to neurologic disease Known allergy or sensitivity to any of the components in the study medication Pregnant and/or breast-feeding The medical conditions of myasthenia gravis, Eaton-Lambert syndrome, or amytrophic lateral sclerosis Symptomatic urinary retention or post-void residual of > 200 mL Anticoagulation therapy Familial bleeding disorder Previous bladder pathology Participation in another drug study Previous botulinum toxin treatment for urological condition
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UI type 100
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Age 63.4
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mean
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10.3
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Men included 0
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Special populations 21
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100
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Race 21
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100
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Notes
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Did participants fail previous treatment? ... Yes ... anticholinergics
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Study years 2008-2009
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Trial name (if given) ND
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Does this paper cite a previous paper from the same study? NO
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Baseline Characteristics
Question Placebo Botulinum toxin Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 10 11 21
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10 11 21
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0 0 0
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Satisfaction with intervention      Population: All Participants
Time Point Measure Placebo Botulinum toxin


Enter a numeric value or title (required) years

N Analyzed
n cured
Outcome: Cure etc.      Population: All Participants
Time Point Measure Placebo Botulinum toxin


6 months

N Analyzed 10 11
n cured 0 6


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 Low RoB
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NRCS.....Patients in different intervention groups selected in an equivalent manner Yes
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)? Not Applicable
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ALL.....Other issues Not Applicable
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ALL....Were interventions adequately described? Yes
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Quality Rating
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