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Study Title and Description

Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE 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 Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial.
Author Orri M., Lipset CH., Jacobs BP., Costello AJ., Cummings SR.
Country Pfizer Ltd, Tadworth, United Kingdom. Electronic address: miguel@orri.co.uk.
Year 2014
Numbers Pubmed ID: 24792229

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 tolterodine
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2 placebo
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries US
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Funding source Industry funded/industry provided materials
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Inclusion criteria Female age >= 21 years with overactive bladder symptoms (subject-reported) for at least 3 months
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Exclusion criteria Clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease. History of cystitis, continence, urogenitalcancer or radiation Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.
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UI type 100
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Age 47.7
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mean
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28, 66
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Men included 0
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Special populations 18
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100
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Race
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13
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72
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3
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17
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2
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11
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Notes Study terminated due to lack of recruitment.
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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) REMOTE
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Does this paper cite a previous paper from the same study?
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Baseline Characteristics
Question tolterodine placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 12 6
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10 6
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2 0
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1 withdrawl; 1 AE
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (urgency)      Population: All Participants
Time Point Measure tolterodine placebo


0 weeks

N Analyzed 10 5
Mean 3.2 2.3
Max 7.7 5.7
Min 1.0 1.0


12 weeks

N Analyzed 11 6
Mean 2.7 2.3
Max 7.7 5.7
Min 1.0 1.0
Within-Arm Comparisons
Comparison Measure tolterodine placebo
12 weeks vs. 0 weeks Mean Difference -1.7 -1.2


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 High RoB differential dropout 1 for tx related AE
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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.