A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice
BELIEVE
Non-Interventional Study Assessing Quality of Life, Treatment Satisfaction, Resource Utilisation, and Persistence With Treatment in Overactive Bladder (OAB) Patients Prescribed Betmiga® - A Multicenter Non-interventional Post Authorisation Study (PAS)
1 other identifier
observational
863
8 countries
60
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2014
CompletedStudy Start
First participant enrolled
November 25, 2014
CompletedFirst Posted
Study publicly available on registry
December 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2016
CompletedOctober 31, 2024
October 1, 2024
1.7 years
November 17, 2014
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Change from baseline in patient treatment satisfaction based on TS-VAS
Baseline up to 12 months post-baseline
Change from baseline in QoL based on the EQ-5D-5L subscales and WPAI:SHP
Baseline up to 12 months post-baseline
Summary of utilisation of healthcare resources related to the management of OAB
From enrollment to end of study (up to 12 months)
Frequency summary of disease progression
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
- +2 more secondary outcomes
Study Arms (1)
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
Interventions
Oral
Eligibility Criteria
Secondary care centers
You may qualify if:
- Patients who have been diagnosed with OAB symptoms at Visit 1 of this study. OAB is defined by the International Urogynecological Association (IUGA)/International Continence Society (ICS) 2010 joint report as urinary urgency, with or without urinary incontinence, usually with frequency and nocturia, with no proven infection or other obvious pathology.
- Patients whose physician has made the decision to prescribe Betmiga® as part of routine clinical practice and who are about to start treatment.
You may not qualify if:
- Patients who are currently taking Betmiga®.
- Contraindication(s) as per the Betmiga® Summary of Product Characteristics (SPC).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Site CZ42009 UROMEDA s. r. o.
Brno, 615 00, Czechia
Site CZ42003 Fakultni nemocnice Brno-Bohunice
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
Related Publications (1)
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.
PMID: 29254376DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Affairs Europe
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
December 19, 2014
Study Start
November 25, 2014
Primary Completion
July 27, 2016
Study Completion
July 27, 2016
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
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/.