Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,355
oral
Oral
Change from baseline in mean number of micturitions per 24 hours
Time frame: Weeks 4, 8 and 12
Change from baseline in mean urgency frequency per 24 hours
Time frame: Weeks 4, 8 and 12
Change from baseline in mean number of incontinence and urge incontinence episodes per 24 hours
Time frame: Weeks 4, 8 and 12
Change from baseline in mean volume voided per micturition
Time frame: Weeks 4, 8 and 12
Change from baseline in number of pads used
Time frame: Weeks 4, 8 and 12
Change from baseline in mean nocturia episodes per 24 hours
Time frame: Weeks 4, 8 and 12
Percentage of patients requiring an increase in the dose of the study medication
Time frame: Weeks 4, 8 and 12
Change from baseline in patient perception of bladder condition
Time frame: Weeks 4, 8 and 12
Patient assessment of treatment benefit
Time frame: Weeks 4, 8 and 12
Physician assessment of treatment benefit
Time frame: Weeks 4, 8 and 12
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Minsk, Belarus
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Antwerp, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Middleheim, Belgium
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Brno, Czechia
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Bulovce, Czechia
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České Budějovice, Czechia
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Mělník, Czechia
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Prague, Czechia
...and 85 more locations