Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
973
oral
oral
Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4
Time frame: Week 16
Change from baseline in mean number of urgency episodes (PPIUS grades 1-4)
Time frame: Week 16
Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours
Time frame: Week 16
Change from baseline in patient perception of bladder condition (PBC)
Time frame: Week 16
Change from baseline in patient perception of urgency 'bother' (UB-VAS)
Time frame: Week 16
Percentage of patients requiring an increase in the dose of the study medication
Time frame: Week 8
Patient assessment of treatment satisfaction (TS-VAS)
Time frame: Weeks 4, 8 and 12
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Unnamed facility
Antwerp, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Liège, Belgium
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Ostrava, Czechia
Unnamed facility
Prague, Czechia
...and 68 more locations