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Study Title and Description

Clinical safety, tolerability and efficacy of combination tolterodine/pilocarpine in patients with overactive bladder.



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 Clinical safety, tolerability and efficacy of combination tolterodine/pilocarpine in patients with overactive bladder.
Author Dmochowski RR., Staskin DR., Duchin K., Paborji M., Tremblay TM.
Country Department of Urology, Vanderbilt University, Nashville, TN, USA.
Year 2014
Numbers Pubmed ID: 24666884

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Tolterodine/Pilocarpine
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2 Tolterodine 2 mg twice daily
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3 Placebo twice daily
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Australia, New Zealand, South Korea
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Funding source Industry funded/industry provided materials
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Inclusion criteria Women 18–75 years of age with a history of OAB (urge or mixed urinary incontinence with predominant urge incontinence) for at least 6 months
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Exclusion criteria predominant stress incontinence or mixed incontinence post void residual urine volume > 100 ml or polyuria (> 3 l/day) underlying neurological disease responsible for OAB active urinary tract infection clinically relevant cardiac arrhythmias Pelvic or urologic abnormalities Bladder urinary tract surgery Patients taking medications with antimuscarinic or antihistaminic activity
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UI type
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0
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100
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Urge or Mixed
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Age 56
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mean
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12.2
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18-75
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Men included 0
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Special populations 130
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100
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Race
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75
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57.7
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53
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40.8
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Notes
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Did participants fail previous treatment? Not reported/unclear
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Study years ND
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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 Tolterodine/Pilocarpine Tolterodine Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow ND ND ND 138
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124 126 123 130
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ND ND ND 8
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Notes No data entered.



Results & Comparisons

No Results found.

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") 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)? Not Applicable
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ALL.....Other issues Not Applicable
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ALL....Were interventions adequately described? Yes
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Quality Rating
No quality rating data was found.