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A study to understand the impact of Betmiga® on patients quality of life, satisfaction with treatment, how long patients remain on treatment, patterns of healthcare resource utilisation, and safety as prescribed by the physicians in routine clinical practice.
Single arm, hybrid model study, observing patients on Betmiga under conditions of routine clinical practice, with some element of retrospective data collection 2 years prior to enrolment of the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. OAB patients taking Betmiga® | OAB patients whose physician has made the decision to prescribe Betmiga® as part of routine clinical practice and who are about to start treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betmiga® | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QoL based on the OAB-q subscales | Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales | Baseline up to 12 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in patient treatment satisfaction based on TS-VAS | Based on Treatment Satisfaction Visual Analogue Scale (TS-VAS) | Baseline up to 12 months post-baseline |
| Change from baseline in QoL based on the EQ-5D-5L subscales and WPAI:SHP |
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Inclusion Criteria:
Exclusion Criteria:
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Secondary care centers
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs Europe | Astellas Pharma Europe Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CZ42009 UROMEDA s. r. o. | Brno | 615 00 | Czechia | |||
| Site CZ42003 Fakultni nemocnice Brno-Bohunice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29254376 | Derived | Freeman R, Foley S, Rosa Arias J, Vicente E, Grill R, Kachlirova Z, Stari A, Huang M, Choudhury N. Mirabegron improves quality-of-life, treatment satisfaction, and persistence in patients with overactive bladder: a multi-center, non-interventional, real-world, 12-month study. Curr Med Res Opin. 2018 May;34(5):785-793. doi: 10.1080/03007995.2017.1419170. Epub 2018 Jan 10. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website. | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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QoL based on Work Productivity Activity Index:Specific Health Problem (WPAI:SHP) and EUROQOL 5-DIMENSIONS (EQ5D)
| Baseline up to 12 months post-baseline |
| Summary of utilisation of healthcare resources related to the management of OAB | Overactive bladder (OAB) healthcare resources are captured by the investigator and include: healthcare visits, medical interventions, number of incontinence pads used in last 7 days, invasive/surgical treatments of OAB symptoms and any other investigations of OAB (including clinical interpretation if available) | From enrollment to end of study (up to 12 months) |
| Frequency summary of disease progression | Disease progression is defined by occurrence of invasive/surgical treatment of OAB symptoms during the study. Overactive Bladder (OAB) treatments include e.g. Botulinum toxin type A, Sacral Neural Stimulation (SNS), Percutaneous tibial nerve stimulation (PTNS) | From enrollment to end of study (up to 12 months |
| Change from baseline in incontinence status during the study | Baseline up to 12 months post-baseline |
| Safety assessed by recording of AEs and ADRs during the study | Adverse Events (AEs), Adverse Drug Reaction (ADR) | From enrollment to end of study (up to 12 months) |
| Summary of prescription status to assess treatment patterns and persistence with treatment | This composite summary includes the following items:
| Baseline up to 12 months post-baseline |
| Brno |
| Czechia |
| Site CZ42006 Hospital Kyjov | Kyjov | Czechia |
| Site CZ42002 Fakultni nemocnice Kralovske Vinohrady | Prague | Czechia |
| Site CZ42007 MEDICON a.s. | Prague | Czechia |
| Site CZ42008 Oblastni nemocnice Pribram | Příbram | Czechia |
| Site CZ42004 Krajská nemocnice Tomáše Bati | Zlín | Czechia |
| Site DK45003 Sygehus Vendsyssel, Frederikshavn | Frederikshavn | 9900 | Denmark |
| Site DK45004 Regionshospitalet Herning | Herning | 7440 | Denmark |
| Site GR30002 University Hospital of Crete | Heraklion | Crete | 71110 | Greece |
| Site GR30009 PGH Laiko | Athens | 11527 | Greece |
| Site GR30001 General Hospital of Athens "Alexandra" | Athens | 11528 | Greece |
| Site GR30007 Sismanoglio General Hospital | Athens | 151 26 | Greece |
| Site GR30011 General Hospital of Heraklion 'Venizelio-Pananio' | Heraklion | 71409 | Greece |
| Site GR30008 University Hospital of Ioannina | Ioannina | 45445 | Greece |
| Site GR30013 University Hospital of Ioannina | Ioannina | 45500 | Greece |
| Site GR30005 University Hospital of Larissa | Larissa | 41110 | Greece |
| Site GR30003 University Hospital of Patras | Pátrai | 26504 | Greece |
| Site GR30006 Papageorgiou General Hospital | Thessaloniki | 56403 | Greece |
| Site GR30012 Papageorgiou General Hospital of Thessaloniki | Thessaloniki | 56403 | Greece |
| Site IE35304 Midland Regional Hospital | Mullingar | Co. Westmeath | Ireland |
| Site IE35302 Coombe Hospital | Dublin | Ireland |
| Site IE35303 Kerry General Hospital | Kerry | Ireland |
| Site SK42101 Univerzitná nemocnica Bratislava - Kramáre | Bratislava | 833 05 | Slovakia |
| Site SK42106 UROCENTRUM LEVICE, s.r.o. | Levice | 934 01, | Slovakia |
| Site SK42102 UROAMB, s.r.o. | Liptovský Mikuláš | 03101 | Slovakia |
| Site SK42104 Urologicka ambulancia, Miramed, sro | Rimavská Sobota | 979 01 | Slovakia |
| Site SK42107 Private Urological Care Center | Trenčín | Slovakia |
| Site SK42103 CMFF, sro | Vranov nad Topľou | 093 01 | Slovakia |
| Site SK42105 ProCare Ziar nad Hronom | Žiar nad Hronom | 965 63 | Slovakia |
| Site ES34005 Corporació Sanitaria Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Site ES34012 H. de Mendaro | Mendaro | Guipuzcoa | 20850 | Spain |
| Site ES34015 Centro Médico Teknon | Barcelona | 08022 | Spain |
| Site ES34007 Hospital Universitario Vall D'Hebron | Barcelona | 08035 | Spain |
| Site ES34017 Hospital de Mollet | Barcelona | Spain |
| Site ES34020 Hospital Universitario Basurto | Bilbao | 48013 | Spain |
| Site ES34009 Hospital Comarcal Santiago Apostol | Burgos | 09200 | Spain |
| Site ES34021 H. de Donostia | Donostia / San Sebastian | 20014 | Spain |
| Site ES34019 Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| Site ES34011 Hospital del Rio Hortega | Valladolid | 47011 | Spain |
| Site ES34010 Policlínico de Vigo, S.A.-POVISA | Vigo | 36211 | Spain |
| Site SE46002 Urologkliniken Carlanderska | Gothenburg | 412 55 | Sweden |
| Site GB44005 Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Site GB44011 Royal Blackburn Hospital | Burnley | BB10 2PQ | United Kingdom |
| Site GB44016 Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Site GB44009 St. Richards Hospital | Chichester | PO19 6SE | United Kingdom |
| Site GB44007 Northampton General Hospital | Cliftonville | NN1 5BD | United Kingdom |
| Site GB44015 University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Site GB44008 Croydon University Hospital | Croydon | CR7 7YE | United Kingdom |
| Site GB44003 Derriford Hospital | Derriford | PL6 8DH | United Kingdom |
| Site GB44019 Northern Devon Healthcare | Devon | EX31 4JB | United Kingdom |
| Site GB44001 Medway Hospital | Gillingham | ME5 7NY | United Kingdom |
| Site GB44004 Southern General Hospital | Glasgow | G51 4TF | United Kingdom |
| Site GB44013 Hinchingbrooke Hospital | Huntingdon | PE29 6NT | United Kingdom |
| Site GB44010 The Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Site GB44014 The Queen Elizabeth Hospital King's Lynn NHS Trust | Norfolk | PE30 4ET | United Kingdom |
| Site GB44002 The Royal Berkshire Hospital | Reading | RG1 5AN | United Kingdom |
| Site GB44018 Salisbury District Hospital | Salisbury | SP2 8BJ | United Kingdom |
| Site GB44017 Sunderland Royal University Hospital | Sunderland | SR4 7TP | United Kingdom |
| Site GB44006 New Cross Hospital | Wolverhampton | WV10 OQP | United Kingdom |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014570 | Urologic Diseases |
| D001745 | Urinary Bladder Diseases |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C520025 | mirabegron |
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