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Study Title and Description

Oxybutynin and tolterodine in a trial for treatment of overactive bladder in Iranian women.



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 Oxybutynin and tolterodine in a trial for treatment of overactive bladder in Iranian women.
Author Aziminekoo, E., Ghanbari, Z., Hashemi, S., Nemati, M., Haghollahi, F., Shokuhi, N.
Country Reproductive Health Research Center, Tehran University of Medical Science, Tehran, Iran.
Year 2014
Numbers Pubmed ID: 24971138

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Oxybutynin Hydrochloride
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2 Tolterodin
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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 with documented over active bladder syndrome [urinary frequency (>or=8 micturations /24 hours) plus urge incontinence (>or=5 episodes/week)] who show idiopathic detrussor overactivity (IDO) in the filling cystometry.
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Exclusion criteria nd
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UI type 100
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Age 53
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mean
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12
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nd
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Men included 0
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Special populations nd
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100
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Race nd
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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, 2012
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Trial name (if given)
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question Oxybutynin Hydrochloride Tolterodin Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow nd nd 100
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nd nd nd
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nd nd nd
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (urgency)      Population: All Participants
Time Point Measure Oxybutynin Hydrochloride Tolterodin


4 weeks

proportion 0.22 0.164
p-value 0 0.035
Outcome: Incontinence count/frequency (urgency)      Population: All Participants
Time Point Measure Oxybutynin Hydrochloride Tolterodin


4 weeks

proportion 0.588 0.418
p-value 0.008 0
Outcome: Incontinence count/frequency (urgency)      Population: All Participants
Time Point Measure Oxybutynin Hydrochloride Tolterodin


4 weeks

proportion 0.397 0.391
p-value 0.001 0.001
Outcome: Incontinence count/frequency (urgency)      Population: All Participants
Time Point Measure Oxybutynin Hydrochloride Tolterodin


4 weeks

proportion 0.467 0.397
p-value 0.001 0.002
P-Value
Outcome: Adverse events      Population: All Participants Between-Arm Comparisons
Time Point Measure Oxybutynin Hydrochloride Tolterodin Comparison Measure Oxybutynin Hydrochloride vs. Tolterodin


4 weeks

proportion 0.06 0.08 0.082
Outcome: Adverse events      Population: All Participants
Time Point Measure Oxybutynin Hydrochloride Tolterodin


4 weeks

proportion 0.30 0.26
Outcome: Incontinence count/frequency (urgency)      Population: All Participants
Time Point Measure Oxybutynin Hydrochloride Tolterodin


4 weeks

proportion 0.176 0.243
p-value 0.035 0.006


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")
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ALL.....Incomplete results data (attrition bias)
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ALL....Group similarity at baseline (selection bias)
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ALL.....Compliance with interventions
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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?
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Quality Rating
No quality rating data was found.