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Study Title and Description

The efficacy and safety of solifenacin in patients with overactive bladder syndrome.



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 The efficacy and safety of solifenacin in patients with overactive bladder syndrome.
Author Oresković S., But I., Banović M., Goldstajn MS.
Country University of Zagreb, School of Medicine, Department of Gynecology and Obstetrics, Zagreb, Croatia.
Year 2012
Numbers Pubmed ID: 22816227

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Solifenacin 5 mg daily
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2 Placebo daily
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Croatia, Slovenia
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Funding source Not reported
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Inclusion criteria Urge incontinence, frequency of micturition (at least 8 voids per 24 hours) and urgency (a strong desire to void at least once per day).
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Exclusion criteria Contraindications for the use of antimuscarinic drugs (e.g. uncontrolled narrow-angle glaucoma, urinaryor gastric retention), stress urinary incontinence (more than one episode per week), bladder outlet obstruction and /or a post-void residual volume more than 200 mL, genitourinary condition that could cause urinary symptoms, recent urogenital surgery or hepatic disease.
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UI type 100
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OAB symptoms for at least 6 months
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Age 56.9
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mean
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10.1
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ND
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ND
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Men included 0
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Special populations 157
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100
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Race 157
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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 ND
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Trial name (if given) ND
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Does this paper cite a previous paper from the same study? No
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Baseline Characteristics
Question Solifenacin Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow ND ND 171
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77 80 157
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ND ND 14
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Satisfaction with intervention      Population: All Participants
Time Point Measure Solifenacin Placebo


0 weeks

N Analyzed
Counts


4 weeks

N Analyzed
Counts
Outcome: Cure etc.      Population: All Participants
Time Point Measure Solifenacin Placebo


3 months

N Analyzed 77 80
Counts 71 68
Outcome: Adverse events      Population: All Participants
Time Point Measure Solifenacin Placebo


Enter a numeric value or title (required) years

note AE reported only for solifenacin, so equivalent to single arm; therefore, not extracted. Also reported discontinuation rates, but data are uninterpretable.


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") High 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)? Yes
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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.