Clinical trial NCT02320773: A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urgency Incontinence
Urinary Bladder Overactive
Overactive Bladder
Urologic Diseases
Urinary Bladder Diseases
Keywords: Overactive Bladder
Quality of Life
Betanis®
Betmiga®
Observational
Myrbetriq®
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-12-19
Enrollment: 863
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Secondary care centers

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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who are currently taking Betmiga®.
* Contraindication(s) as per the Betmiga® Summary of Product Characteristics (SPC).

Primary outcomes:
measure: Change from baseline in QoL based on the OAB-q subscales
timeFrame: Baseline up to 12 months post-baseline
Secondary outcomes:
measure: Change from baseline in patient treatment satisfaction based on TS-VAS
timeFrame: Baseline up to 12 months post-baseline
measure: Change from baseline in QoL based on the EQ-5D-5L subscales and WPAI:SHP
timeFrame: Baseline up to 12 months post-baseline
measure: Summary of utilisation of healthcare resources related to the management of OAB
timeFrame: From enrollment to end of study (up to 12 months)
measure: Frequency summary of disease progression
timeFrame: From enrollment to end of study (up to 12 months
measure: Change from baseline in incontinence status during the study
timeFrame: Baseline up to 12 months post-baseline
measure: Safety assessed by recording of AEs and ADRs during the study
timeFrame: From enrollment to end of study (up to 12 months)
measure: Summary of prescription status to assess treatment patterns and persistence with treatment
timeFrame: Baseline up to 12 months post-baseline
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Site CZ42009 UROMEDA s. r. o.
city: Brno
country: Czechia
facility: Site CZ42003 Fakultni nemocnice Brno-Bohunice
city: Kyjov
country: Czechia
facility: Site CZ42006 Hospital Kyjov
city: Praha 10
country: Czechia
facility: Site CZ42002 Fakultni nemocnice Kralovske Vinohrady
city: Praha 4
country: Czechia
facility: Site CZ42007 MEDICON a.s.
city: Příbram
country: Czechia
facility: Site CZ42008 Oblastni nemocnice Pribram
city: Zlín
country: Czechia
facility: Site CZ42004 Krajská nemocnice Tomáše Bati
city: Frederikshavn
country: Denmark
facility: Site DK45003 Sygehus Vendsyssel, Frederikshavn
city: Herning
country: Denmark
facility: Site DK45004 Regionshospitalet Herning
city: Heraklion
country: Greece
facility: Site GR30002 University Hospital of Crete
state: Crete
city: Athens
country: Greece
facility: Site GR30009 PGH Laiko
city: Athens
country: Greece
facility: Site GR30001 General Hospital of Athens "Alexandra"
city: Athens
country: Greece
facility: Site GR30007 Sismanoglio General Hospital
city: Heraklion
country: Greece
facility: Site GR30011 General Hospital of Heraklion 'Venizelio-Pananio'
city: Ioannina
country: Greece
facility: Site GR30008 University Hospital of Ioannina
city: Ioannina
country: Greece
facility: Site GR30013 University Hospital of Ioannina
city: Larisa
country: Greece
facility: Site GR30005 University Hospital of Larissa
city: Patras
country: Greece
facility: Site GR30003 University Hospital of Patras
city: Thessaloniki
country: Greece
facility: Site GR30006 Papageorgiou General Hospital
city: Thessaloniki
country: Greece
facility: Site GR30012 Papageorgiou General Hospital of Thessaloniki
city: Mullingar
country: Ireland
facility: Site IE35304 Midland Regional Hospital
state: Co. Westmeath
city: Dublin 8
country: Ireland
facility: Site IE35302 Coombe Hospital
city: Kerry
country: Ireland
facility: Site IE35303 Kerry General Hospital
city: Bratislava 3
country: Slovakia
facility: Site SK42101 Univerzitná nemocnica Bratislava - Kramáre
city: Levice
country: Slovakia
facility: Site SK42106 UROCENTRUM LEVICE, s.r.o.
city: Liptovský Mikuláš
country: Slovakia
facility: Site SK42102 UROAMB, s.r.o.
city: Rimavská Sobota
country: Slovakia
facility: Site SK42104 Urologicka ambulancia, Miramed, sro
city: Trenčín
country: Slovakia
facility: Site SK42107 Private Urological Care Center
city: Vranov Nad Topľou
country: Slovakia
facility: Site SK42103 CMFF, sro
city: Žiar Nad Hronom
country: Slovakia
facility: Site SK42105 ProCare Ziar nad Hronom
city: Sabadell
country: Spain
facility: Site ES34005 Corporació Sanitaria Parc Taulí
state: Barcelona
city: Mendaro
country: Spain
facility: Site ES34012 H. de Mendaro
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Site ES34015 Centro Médico Teknon
city: Barcelona
country: Spain
facility: Site ES34007 Hospital Universitario Vall D'Hebron
city: Barcelona
country: Spain
facility: Site ES34017 Hospital de Mollet
city: Bilbao
country: Spain
facility: Site ES34020 Hospital Universitario Basurto
city: Burgos
country: Spain
facility: Site ES34009 Hospital Comarcal Santiago Apostol
city: Lugo
country: Spain
facility: Site ES34019 Hospital Universitario Lucus Augusti
city: San Sebastian
country: Spain
facility: Site ES34021 H. de Donostia
city: Valladolid
country: Spain
facility: Site ES34011 Hospital del Rio Hortega
city: Vigo
country: Spain
facility: Site ES34010 Policlínico de Vigo, S.A.-POVISA
city: Göteborg
country: Sweden
facility: Site SE46002 Urologkliniken Carlanderska
city: Bradford
country: United Kingdom
facility: Site GB44005 Bradford Royal Infirmary
city: Burnley
country: United Kingdom
facility: Site GB44011 Royal Blackburn Hospital
city: Cambridge
country: United Kingdom
facility: Site GB44016 Addenbrookes Hospital
city: Chichester
country: United Kingdom
facility: Site GB44009 St. Richards Hospital
city: Cliftonville
country: United Kingdom
facility: Site GB44007 Northampton General Hospital
city: Coventry
country: United Kingdom
facility: Site GB44015 University Hospital Coventry
city: Croydon
country: United Kingdom
facility: Site GB44008 Croydon University Hospital
city: Derriford
country: United Kingdom
facility: Site GB44003 Derriford Hospital
city: Devon
country: United Kingdom
facility: Site GB44019 Northern Devon Healthcare
city: Gillingham
country: United Kingdom
facility: Site GB44001 Medway Hospital
city: Glasgow
country: United Kingdom
facility: Site GB44004 Southern General Hospital
city: Huntingdon
country: United Kingdom
facility: Site GB44013 Hinchingbrooke Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Site GB44010 The Freeman Hospital
city: Norfolk
country: United Kingdom
facility: Site GB44014 The Queen Elizabeth Hospital King's Lynn NHS Trust
city: Reading
country: United Kingdom
facility: Site GB44002 The Royal Berkshire Hospital
city: Salisbury
country: United Kingdom
facility: Site GB44018 Salisbury District Hospital
city: Sunderland
country: United Kingdom
facility: Site GB44017 Sunderland Royal University Hospital
city: Wolverhampton
country: United Kingdom
facility: Site GB44006 New Cross Hospital
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Medical Affairs Europe
role: STUDY_DIRECTOR
References:
citation: 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.