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Study Title and Description

Effect of fesoterodine on urethral closure function in women with stress urinary incontinence assessed by urethral pressure reflectometry.



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 Effect of fesoterodine on urethral closure function in women with stress urinary incontinence assessed by urethral pressure reflectometry.
Author Klarskov N., Darekar A., Scholfield D., Whelan L., Lose G.
Country Department of Obstetrics and Gynecology, Herlev Hospital, Herlev Ringvej 75, Herlev, Denmark, niels.klarskov@regionh.dk.
Year 2014
Numbers Pubmed ID: 24258099

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Fesoterodine 4 mg
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2 Fesoterodine 8 mg
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3 Placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Denmark
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Funding source Industry funded/industry provided materials
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Inclusion criteria 18-65 years, stress incontinence >3 months, stress predominant mixed urinary incontinence >3 months
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Exclusion criteria significant neurological disease, trauma, prescription or non-prescription drug use affecting the lower urinary tract within 14 days of first treatment period, history of lower urinary tract or pelvic surgery or irradiation to the pelvis, anatomical anomaly of the urinary tract, urinary retention or outlet obstruction, catheter, bladder training in the last 3 months, hematuria, URI, drug therapy for overactive bladder
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UI type
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100
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Age 47.9
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mean
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8.4
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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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100
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years 2010
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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 Fesoterodine 4 mg Fesoterodine 8 mg Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 20 22 20 22
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20 18 20 18
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0 4 0 4
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1 AE, 1 not treatment related, 1 protocol violation
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (total)      Population: All Participants
Time Point Measure Fesoterodine 4 mg Fesoterodine 8 mg Placebo


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N Analyzed 20 18 20
Mean -0.81 -0.54 -0.70
SD 0.9 1.1 0.9
Outcome: Incontinence count/frequency (stress)      Population: All Participants
Time Point Measure Fesoterodine 4 mg Fesoterodine 8 mg Placebo


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N Analyzed 20 22 20
Mean -0.75 -0.46 -0.62
SD 0.8 1.0 0.9
Outcome: Incontinence count/frequency (urgency)      Population: All Participants
Time Point Measure Fesoterodine 4 mg Fesoterodine 8 mg Placebo


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N Analyzed 20 22 20
Mean -0.06 -0.08 -0.08
SD 0.2 0.3 0.3


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment Unclear RoB allocation methods not specified
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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 all participants completed the 3 crossover arms.
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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 Not Applicable
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)? Not Applicable
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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