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Study Title and Description

Pharmacologic treatment for urgency-predominant urinary incontinence in women diagnosed using a simplified algorithm: a randomized 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 Pharmacologic treatment for urgency-predominant urinary incontinence in women diagnosed using a simplified algorithm: a randomized trial.
Author Huang AJ., Hess R., Arya LA., Richter HE., Subak LL., Bradley CS., Rogers RG., Myers DL., Johnson KC., Gregory WT., Kraus SR., Schembri M., Brown JS.
Country Department of Medicine, University of California San Francisco School of Medicine, San Francisco, CA, USA. ahuang@ucsfmed.org
Year 2012
Numbers Pubmed ID: 22542122

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 placebo
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2 fesoterodine
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries United States
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Funding source Industry funded/industry provided materials
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Inclusion criteria woman ≥ 18 years old, isolated urgency incontinence or mixed incontinence, ≥ 7 incontinence episodes per week in the past 3 months
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Exclusion criteria self-reported complex medical history (incontinence surgery in last 5 years, pelvic surgery in last 6 months), >3 UTI in last year, urinary tract or rectal fistula, interstitial cystitis, symptomatic pelvic organ prolapse, urogenital cancer or radiation, congenital abnormalities leading to incontinence, major neurological disorder, patients with contraindications to fesoterodine therapy.
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UI type 100
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clinically frequent incontinence (≥ 7 episodes per week for 3 months) identified as having urgency-predominant incontinence on the 3IQ
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Age 56
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mean
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14
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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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427
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66.2
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144
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22.3
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46
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7.1
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15
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2.3
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13
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2.0
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2009-2010
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Trial name (if given)
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Does this paper cite a previous paper from the same study? no
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Baseline Characteristics
Question placebo fesoterodine Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 323 322 645
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301 303 604
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22 19 41
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Notes 2 patients did not receive intervention, 22 not analyzed 1 patient did not receive intervention, 19 not analyzed
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Results & Comparisons


Results Data
Outcome: Adverse events      Population: All Participants
Time Point Measure placebo fesoterodine


Enter a numeric value or title (required) years

N Analyzed
Counts
Outcome: Quality of life      Population: All Participants
Time Point Measure placebo fesoterodine


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N Analyzed
Counts
Outcome: Cure etc.      Population: All Participants
Time Point Measure placebo fesoterodine


12 weeks

N Analyzed 301 303
Counts 34 79
Mean Difference 95% CI low 95% CI high P-Value
Outcome: Incontinence count/frequency (total)      Population: All Participants Between-Arm Comparisons
Time Point Measure placebo fesoterodine Comparison Measure ERROR vs. ERROR


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N Analyzed
SD
Least Squares Mean
Mean
Mean Difference 95% CI low 95% CI high P-Value
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure placebo fesoterodine Comparison Measure ERROR vs. ERROR


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N Analyzed
SD
Least Squares Mean
Mean


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 Unclear 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)? Yes
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ALL.....Other issues
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ALL....Were interventions adequately described? Yes
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Quality Rating
Guideline Used Overall Rating