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Study Title and Description

Comparison of two selective muscarinic receptor antagonists (solifenacin and darifenacin) in women with overactive bladder--the SOLIDAR study.



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 Comparison of two selective muscarinic receptor antagonists (solifenacin and darifenacin) in women with overactive bladder--the SOLIDAR study.
Author But I., Goldstajn MS., Oresković S.
Country University of Maribor, Maribor University Clinical Centre, General Gynaecology and Urogynaecology Department, Gynaecology and Perinatology Clinic, Maribor, Slovenia. but.igor@gmail.com
Year 2012
Numbers Pubmed ID: 23390832

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


Extraction Form: All studies
Arms
Number Title Description Comments
1 Solifenacin Solifenacin 5 mg
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2 Darifenacin Darifenacin 7.5 mg
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Design Details
Question... Follow Up Answer Follow-up Answer
Study type RCT
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Country/countries Slovenia
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Funding source Not reported
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Inclusion criteria female, urgency intensity and urgency urinary incontinence of ≥3 on the Urgency Perception Scale (UPS), and frequency ≥1 urgency episodes per day, no anticholinergic drugs for at least 6 months prior to study inclusion
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Exclusion criteria pregnant, angular glaucoma, urinary infection, urinary tract stones, bladder disease (stones or tumors), dementia, neurogenic OAB with sever orthopedic difficulties
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UI type
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100
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Age 54
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medan
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11.5
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Men included 0
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Special populations 77
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100
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Race 77
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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 2007-2008
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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 Solifenacin Darifenacin Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Participant flow 40 37 77
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32 29 61
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8 8 16
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2 withdrew consent, 2 lack of efficacy, 4 adverse events 1 withdrew consent, 2 lack of efficacy, 4 adverse event, 1 physician's advice
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Notes No data entered.



Results & Comparisons


Results Data
Outcome: Incontinence count/frequency (total)      Population: All Participants Between-Arm Comparisons
Time Point Measure Solifenacin Darifenacin Comparison Measure Solifenacin vs. Darifenacin


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N Analyzed 39 33 Median Difference 0.3
SD 2.0 2.7 SD 2.4
Median -1.78 -2.0 P-Value 0.82
Outcome: Incontinence count/frequency (total)      Population: All Participants Between-Arm Comparisons
Time Point Measure Solifenacin Darifenacin Comparison Measure Solifenacin vs. Darifenacin


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N Analyzed 32 29 Median Difference -0.1
SD 2.5 3.4 SD 2.99
Median -2.17 -2.1 P-Value 0.70
Outcome: Urgency bother by VAS (0–100)      Population: All Participants Between-Arm Comparisons
Time Point Measure Solifenacin Darifenacin Comparison Measure Solifenacin vs. Darifenacin


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N Analyzed 32 29 Median Difference 22.5
Median 84 55 P-Value 0.010
25th Percentile 55.0 33.0
75th Percentile 92.5 88.0


Quality Dimensions
Dimension Value Notes Comments
RCT:.....Adequate generation of a randomized sequence Low RoB
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RCT:.....Allocation concealment High RoB open label study
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RCT:.....Blinding of PATIENTS High RoB open label study
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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 open label study
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ALL.....Incomplete results data (attrition bias) Low RoB
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ALL....Group similarity at baseline (selection bias) Unclear RoB baseline characteristics not described
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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 Not Applicable
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NRCS....Baseline differences between groups accounted for (Adjusted analysis)? Not Applicable
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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.