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Study Title and Description

Investigation of the clinical efficacy and safety of pregabalin alone or combined with tolterodine in female subjects with idiopathic 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 Investigation of the clinical efficacy and safety of pregabalin alone or combined with tolterodine in female subjects with idiopathic overactive bladder.
Author Marencak J., Cossons NH., Darekar A., Mills IW.
Country Hospital with Policlinic Skalica, Skalica, Slovakia.
Year 2011
Numbers Pubmed ID: 20886571

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Standard-dose pregabalin and tolterodine pregabalin 150 mg twice daily + tolterodine ER 4 mg once daily
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2 Low-dose pregabalin and tolterodine pregabalin 75 mg twice daily + tolterodine ER 2 mg once daily
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3 Pregabalin 150 mg Pregabalin 150mg twice daily
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4 Tolterodine ER 4 mg Tolterodine ER 4 mg once daily
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5 Placebo No treatment
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Czech Republic Lithuania Norway Slovakia Sweden United Kingdom
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Funding source Industry funded/industry provided materials
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Inclusion criteria women ≥18 years, urinary frequency ≥8 micturitions on aver per 24 hours, ≥4 episodes of urgency/week, mean voided volume <300ml in a 5 day bladder diary
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Exclusion criteria OAB symtoms <6 months before randomization, significant stress urinary incontinence, UTI, chronic persistent urinary tract pathology, relevant neurologic disease associated with urinary symptoms, <3 bowel movements/week, cystocele or other clinically significant pelvic prolapse, mean total voided volume >3000 ml in 24 hours, postvoidal residual volume of >200 ml, previous bladder radiotherapy, catheterization or assistance required for toileting
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UI type 100
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sudden and compelling desire to pass urine that is difficult to defer
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Directionality Prospective
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Age 52.9
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mean
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13.3
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Men included 0
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Special populations 164
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100
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no special populations
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Race 164
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100
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no race reported
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Notes no baseline characteristics other than mean age
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Did participants fail previous treatment? Not reported/unclear
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Study years 2005-2006
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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 Standard-dose pregabalin and tolterodine Low-dose pregabalin and tolterodine Pregabalin 150 mg Tolterodine ER 4 mg Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 102 105 105 104 103 186
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96 100 99 101 101 164
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6 5 6 3 2 22
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3 AE related, 1 not AE related, 1 subject defaulted, 1 other reason 2 AE related, 2 subject defaulted, 1 lack of efficacy 5 AE related, 1 subject defaulted 2 lack of efficacy, 1 subject defaulted 1 AE related, 1 subject defaulted
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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 Unsure baseline characteristics not transparent
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)? No Data baseline characteristics not transparent
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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.