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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with residual OAB symptoms | Urge urinary incontinence, urgency, and frequency after treatment with other antimuscarinics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin | Drug | Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score | baseline, month 6 and 12 | |
| Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS) | baseline, month 6 and 12 | |
| Change from baseline in EuroQol Group system (EQ-5D-5L) score | baseline, month 6 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QoL according to previous antimuscarinic treatment and sex (assessed by: TS-VAS score, OAB-q SF score, EQ-5D-5L) | 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 |
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Inclusion Criteria:
Patient willing and able to complete the questionnaires
Diagnosis of OAB
Previous unsuccessful OAB medication (antimuscarinic treatment for at least 1 month) less than 4 weeks ago defined by:
Eligible to start Vesicare™ 5 or 10 mg according to Summary of Product Characteristics (SmPC)
Exclusion Criteria:
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Patients with OAB symptoms being treated by urologists in Czech Republic
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CZ42003 Private Practice | Benešov | Czechia | ||||
| Site CZ42001 Private Practice |
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|
| 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)) | 12 months |
| Occurence of adverse drug reaction | 12 months |
| Beroun |
| Czechia |
| Site CZ42014 Private Practice | Blansko | Czechia |
| Site CZ42023 Private Practice | Boskovice | Czechia |
| Site CZ42032 Private Practice | Brno | Czechia |
| Site CZ42034 Hospital | Brno | Czechia |
| Site CZ42035 Private Practice | Brno | Czechia |
| Site CZ42036 Private Practice | Brno | Czechia |
| Site CZ42038 Private Practice | Brno | Czechia |
| Site CZ42039 Private Practice | Brno | Czechia |
| Site CZ42058 Hospital | Brno | Czechia |
| Site CZ42059 Hospital | Brno | Czechia |
| Site CZ42025 Private Practice | Cheb | Czechia |
| Site CZ42048 Private Practice | Dvůr Králové | Czechia |
| Site CZ42040 Private Practice | Havlíčkův Brod | Czechia |
| Site CZ42015 Private Practice | Hodonín | Czechia |
| Site CZ42045 Private Practice | Hradec Králové | Czechia |
| Site CZ42051 Private Practice | Jičín | Czechia |
| Site CZ42027 Private Practice | Jindřichŭv Hradec | Czechia |
| Site CZ42029 Private Practice | Jindřichŭv Hradec | Czechia |
| Site CZ42026 Private Practice | Karlovy Vary | Czechia |
| Site CZ42028 Private Practice | Karlovy Vary | Czechia |
| Site CZ42030 Private Practice | Klatovy | Czechia |
| Site CZ42049 Private Practice | Litoměřice | Czechia |
| Site CZ42021 Private Practice | Litovel | Czechia |
| Site CZ42050 Private Practice | Most | Czechia |
| Site CZ42054 Private Practice | Ostrava | Czechia |
| Site CZ42055 Private Practice | Ostrava | Czechia |
| Site CZ42056 Private Practice | Ostrava | Czechia |
| Site CZ42057 Private Practice | Ostrava | Czechia |
| Site CZ42005 Private Practice | Pardubice | Czechia |
| Site CZ42008 Private Practice | Pardubice | Czechia |
| Site CZ42024 Private Practice | Pilsen | Czechia |
| Site CZ42002 Private Practice | Prague | Czechia |
| Site CZ42004 Private Practice | Prague | Czechia |
| Site CZ42006 Private Practice | Prague | Czechia |
| Site CZ42007 Private Practice | Prague | Czechia |
| Site CZ42009 Private Practice | Prague | Czechia |
| Site CZ42010 Private Practice | Prague | Czechia |
| Site CZ42011 Private Practice | Prague | Czechia |
| Site CZ42060 Private Practice | Prague | Czechia |
| Site CZ42044 Private Practice | Roudnice nad Labem | Czechia |
| Site CZ42031 Private Practice | Strakonice | Czechia |
| Site CZ42020 Private Practice | Svitavy | Czechia |
| Site CZ42047 Private Practice | Teplice | Czechia |
| Site CZ42053 Private Practice | Teplice | Czechia |
| Site CZ42042 Private Practice | Trutnov | Czechia |
| Site CZ42052 Private Practice | Turnov | Czechia |
| Site CZ42018 Hospital | Uherské Hradiště | Czechia |
| Site CZ42019 Private Practice | Uherské Hradiště | Czechia |
| Site CZ42043 Private Practice | Ústí nad Labem | Czechia |
| Site CZ42046 Private Practice | Ústí nad Labem | Czechia |
| Site CZ42041 Hospital | Velké Meziříčí | Czechia |
| Site CZ42016 Private Practice | Vsetín | Czechia |
| Site CZ42017 Private Practice | Vsetín | Czechia |
| Site CZ42012 Private Practice | Zlín | Czechia |
| Site CZ42013 Private Practice | Zlín | Czechia |
| Site CZ42022 Private Practice | Zlín | Czechia |
| Site CZ42033 Private Practice | Znojmo | Czechia |
| Site CZ42037 Hospital | Znojmo | Czechia |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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