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Study Title and Description

Considering the prominent complaint as a guide in medical therapy for overactive bladder syndrome in women over 45 years.



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 Considering the prominent complaint as a guide in medical therapy for overactive bladder syndrome in women over 45 years.
Author Jafarabadi M., Jafarabadi L., Shariat M., Rabie Salehi G., Haghollahi F., Rashidi BH.
Country Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Year 2015
Numbers Pubmed ID: 25369726

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Oxybutynin
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2 Tolterodine
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Iran
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Funding source Explicitly not industry funded
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Inclusion criteria female outpatients age >= 45 with documented OAB (urinary frequency >= micturations/24 hours plus urge incontinence >=5 episodes/week who show IDO in the filling chemistry
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Exclusion criteria lactation, pregnancy, glaucoma, urinary infection, stress UI, myasthenia gravis, neuropathy, mental disorder, gross renal, hepatic or cardiovascular disorders, obstruction in urinary bladder outlet, history of genitourinary operations, interstitial cystitis, unexplained hematuria, urinary catheterization, concomitant antimuscarinic medication, electrostimulation therapy or bladder training, allergy to oxybutynin or tolterodine, treatment with tolterodine or oxybutynin in the 3 months before randomization and exposure to any other investigational drug in the preceding 2 months.
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UI type 100
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Age 54.9
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mean
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9
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Men included 0
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Special populations 301
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100
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Race 301
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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 2011-2013
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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 Oxybutynin Tolterodine Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 151 150 301
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140 142 282
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11 8 19
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure Oxybutynin Tolterodine Comparison Measure Oxybutynin vs. Tolterodine


0 weeks

N Analyzed 140 142
Mean 2.06 1.56
SD
SE


12 weeks

N Analyzed 140 142 Net P value 0.04
Mean 1.23 0.71
SD
SE
Within-Arm Comparisons
Comparison Measure Oxybutynin Tolterodine
12 weeks vs. 0 weeks P-Value <0.001 <0.001
% improvement 40.1 54.3
Outcome: Incontinence count/frequency (urgency)      Population: All Participants Between-Arm Comparisons
Time Point Measure Oxybutynin Tolterodine Comparison Measure Oxybutynin vs. Tolterodine


0 weeks

N Analyzed 140 142 Net P value
Mean 8.82 8.94
SD
SE


12 weeks

N Analyzed 140 142 Net P value 0.75
Mean 5.24 5.44
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 Unclear RoB dropout reasons not given
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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.