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Study Title and Description

Anticholinergic therapy vs. onabotulinumtoxina for urgency 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 Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence.
Author Visco AG., Brubaker L., Richter HE., Nygaard I., Paraiso MF., Menefee SA., Schaffer J., Lowder J., Khandwala S., Sirls L., Spino C., Nolen TL., Wallace D., Meikle SF.
Country Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC 27707, USA. anthony.visco@duke.edu
Year 2012
Numbers Pubmed ID: 23036134

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 solifenacin
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2 onabotulinumtoxinA
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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 Explicitly not industry funded
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Inclusion criteria women >=5 UUI episodes/day
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Exclusion criteria previously received anticholinergic drugs or up to two anticholinergic medications other than solifenacin, darifenacin, or trospium chloride; residual urine volume of >= 150 ml; previous therapy for urgency urinary incontinence with onabotulinumtoxinA
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UI type 100
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NS
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some had mixed, but % not specified
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Age 58
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mean
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11.3
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Men included 0
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Special populations 247
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100
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Race
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194
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78.5
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41
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16.6
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12
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4.9
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Notes This study not industry funded, but the primary author reports income from industry
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Did participants fail previous treatment? ... Some ... 59% prior anticholinergic therapy
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Study years 2010-2012
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Trial name (if given) ABC
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Does this paper cite a previous paper from the same study? no
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Baseline Characteristics
Question solifenacin onabotulinumtoxinA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 127 122 249
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118 113 231
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9 9 18
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1 not treated, 4 withdrawn, 4 lost to followup 1 not treated, 8 withdrawn
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Adverse events      Population: All Participants
Time Point Measure solifenacin onabotulinumtoxinA


0 months

N Analyzed
Counts
n cured
n improved


6 months

N Analyzed
Counts
n cured
n improved
Outcome: Quality of life      Population: All Participants
Time Point Measure solifenacin onabotulinumtoxinA


0 months

N Analyzed
Counts
n cured
n improved


6 months

N Analyzed
Counts
n cured
n improved
P-Value
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure solifenacin onabotulinumtoxinA Comparison Measure solifenacin vs. onabotulinumtoxinA


6 months

N Analyzed 119 112 0.003 cured; 0.06 improved
Counts
n cured 16 30
n improved 48 61
P-Value
Outcome: Cure etc.      Population: All Participants Between-Arm Comparisons
Time Point Measure solifenacin onabotulinumtoxinA Comparison Measure solifenacin vs. onabotulinumtoxinA


6 months

N Analyzed 119 112 0.003
Counts
n cured 13 26
n improved
P-Value
Outcome: Bladder control, subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure solifenacin onabotulinumtoxinA Comparison Measure solifenacin vs. onabotulinumtoxinA


6 months

N Analyzed 116 111 0.71
Counts 67 60
n cured
n improved
Net P value
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure solifenacin onabotulinumtoxinA Comparison Measure solifenacin vs. onabotulinumtoxinA


0 months

N Analyzed 126 121
Mean 5.2 4.8
SD 2.7 2.7
SE


6 months

N Analyzed 118 113 0.81
Mean
SD
SE
Within-Arm Comparisons
Comparison Measure solifenacin onabotulinumtoxinA
6 months vs. 0 months Mean Difference -3.4 -3.3
Net P value Net P value
Outcome: Bladder control, subjective      Population: All Participants Between-Arm Comparisons
Time Point Measure solifenacin onabotulinumtoxinA Comparison Measure solifenacin vs. onabotulinumtoxinA


0 months

N Analyzed 126 121
Mean
SD
SE


6 months

N Analyzed 123 119 0.87
Mean
SD
SE


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) 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
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.