An observational study in Urinary Bladder, Overactive, sponsored by Astellas Pharma Europe B.V.. Completed at 60 sites in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-13.
Sponsored by Astellas Pharma Europe B.V. · Observational
This is a 12 month non-interventional study with solifenacin succinate, evaluating the effect of solifenacin on quality of life (QoL) of patients previously treated with antimuscarinics (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their treatment with antimuscarinics because of safety and/or efficacy reasons) - measured by Perception of Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on quality of life measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group scoring system (EQ-5D-5L).
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 2,000 is above the median of 109 across 166 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Astellas Pharma Europe B.V. is the lead sponsor of 93 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with OAB symptoms being treated by urologists in Czech Republic
Previous unsuccessful OAB medication (antimuscarinic treatment for at least 1 month) less than 4 weeks ago defined by:
Exclusion Criteria:
Urge urinary incontinence, urgency, and frequency after treatment with other antimuscarinics
Drug: Solifenacin
Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics
Also known as: Vesicare
Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score
Time frame: baseline, month 6 and 12
Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)
Time frame: baseline, month 6 and 12
Change from baseline in EuroQol Group system (EQ-5D-5L) score
Time frame: baseline, month 6 and 12
Change in QoL according to previous antimuscarinic treatment and sex (assessed by: TS-VAS score, OAB-q SF score, EQ-5D-5L)
Time frame: baseline, month 1, 3, 6 and 12
Change from baseline in OAB symptoms assessed by micturition diary
Mean number of urgency episode per 24 hours, mean number of micturition per 24 hours, mean number of nocturia episodes per 24 hours, mean number of urge incontinence (UUI) episodes per week
Time frame: baseline, month 1, 3, 6 and 12
Persistence to therapy (measured by proportion of Days Covered (PDC, threshold of 80 percent during the measurement period), median length of therapy (days))
Time frame: 12 months
Occurence of adverse drug reaction
Time frame: 12 months
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Europe B.V.