A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice

NCT ID: NCT02320773

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

863 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-25

Study Completion Date

2016-07-27

Brief Summary

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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.

Detailed Description

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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

Conditions

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Urgency Incontinence Urinary Bladder Overactive Overactive Bladder Urologic Diseases Urinary Bladder Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Betmiga®

Intervention Type DRUG

Oral

Interventions

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Betmiga®

Oral

Intervention Type DRUG

Other Intervention Names

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YM178 Mirabegron Myrbetriq® Betanis®

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Affairs Europe

Role: STUDY_DIRECTOR

Astellas Pharma Europe Ltd.

Locations

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Site CZ42009 UROMEDA s. r. o.

Brno, , Czechia

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Site CZ42003 Fakultni nemocnice Brno-Bohunice

Brno, , Czechia

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Site CZ42006 Hospital Kyjov

Kyjov, , Czechia

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Site CZ42002 Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

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Site CZ42007 MEDICON a.s.

Prague, , Czechia

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Site CZ42008 Oblastni nemocnice Pribram

Příbram, , Czechia

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Site CZ42004 Krajská nemocnice Tomáše Bati

Zlín, , Czechia

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Site DK45003 Sygehus Vendsyssel, Frederikshavn

Frederikshavn, , Denmark

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Site DK45004 Regionshospitalet Herning

Herning, , Denmark

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Site GR30002 University Hospital of Crete

Heraklion, Crete, Greece

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Site GR30009 PGH Laiko

Athens, , Greece

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Site GR30001 General Hospital of Athens "Alexandra"

Athens, , Greece

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Site GR30007 Sismanoglio General Hospital

Athens, , Greece

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Site GR30011 General Hospital of Heraklion 'Venizelio-Pananio'

Heraklion, , Greece

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Site GR30008 University Hospital of Ioannina

Ioannina, , Greece

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Site GR30013 University Hospital of Ioannina

Ioannina, , Greece

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Site GR30005 University Hospital of Larissa

Larissa, , Greece

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Site GR30003 University Hospital of Patras

Pátrai, , Greece

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Site GR30006 Papageorgiou General Hospital

Thessaloniki, , Greece

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Site GR30012 Papageorgiou General Hospital of Thessaloniki

Thessaloniki, , Greece

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Site IE35304 Midland Regional Hospital

Mullingar, Co. Westmeath, Ireland

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Site IE35302 Coombe Hospital

Dublin, , Ireland

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Site IE35303 Kerry General Hospital

Kerry, , Ireland

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Site SK42101 Univerzitná nemocnica Bratislava - Kramáre

Bratislava, , Slovakia

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Site SK42106 UROCENTRUM LEVICE, s.r.o.

Levice, , Slovakia

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Site SK42102 UROAMB, s.r.o.

Liptovský Mikuláš, , Slovakia

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Site SK42104 Urologicka ambulancia, Miramed, sro

Rimavská Sobota, , Slovakia

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Site SK42107 Private Urological Care Center

Trenčín, , Slovakia

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Site SK42103 CMFF, sro

Vranov nad Topľou, , Slovakia

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Site SK42105 ProCare Ziar nad Hronom

Žiar nad Hronom, , Slovakia

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Site ES34005 Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

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Site ES34012 H. de Mendaro

Mendaro, Guipuzcoa, Spain

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Site ES34015 Centro Médico Teknon

Barcelona, , Spain

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Site ES34007 Hospital Universitario Vall D'Hebron

Barcelona, , Spain

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Site ES34017 Hospital de Mollet

Barcelona, , Spain

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Site ES34020 Hospital Universitario Basurto

Bilbao, , Spain

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Site ES34009 Hospital Comarcal Santiago Apostol

Burgos, , Spain

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Site ES34021 H. de Donostia

Donostia / San Sebastian, , Spain

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Site ES34019 Hospital Universitario Lucus Augusti

Lugo, , Spain

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Site ES34011 Hospital del Rio Hortega

Valladolid, , Spain

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Site ES34010 Policlínico de Vigo, S.A.-POVISA

Vigo, , Spain

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Site SE46002 Urologkliniken Carlanderska

Gothenburg, , Sweden

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Site GB44005 Bradford Royal Infirmary

Bradford, , United Kingdom

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Site GB44011 Royal Blackburn Hospital

Burnley, , United Kingdom

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Site GB44016 Addenbrookes Hospital

Cambridge, , United Kingdom

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Site GB44009 St. Richards Hospital

Chichester, , United Kingdom

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Site GB44007 Northampton General Hospital

Cliftonville, , United Kingdom

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Site GB44015 University Hospital Coventry

Coventry, , United Kingdom

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Site GB44008 Croydon University Hospital

Croydon, , United Kingdom

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Site GB44003 Derriford Hospital

Derriford, , United Kingdom

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Site GB44019 Northern Devon Healthcare

Devon, , United Kingdom

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Site GB44001 Medway Hospital

Gillingham, , United Kingdom

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Site GB44004 Southern General Hospital

Glasgow, , United Kingdom

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Site GB44013 Hinchingbrooke Hospital

Huntingdon, , United Kingdom

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Site GB44010 The Freeman Hospital

Newcastle upon Tyne, , United Kingdom

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Site GB44014 The Queen Elizabeth Hospital King's Lynn NHS Trust

Norfolk, , United Kingdom

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Site GB44002 The Royal Berkshire Hospital

Reading, , United Kingdom

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Site GB44018 Salisbury District Hospital

Salisbury, , United Kingdom

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Site GB44017 Sunderland Royal University Hospital

Sunderland, , United Kingdom

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Site GB44006 New Cross Hospital

Wolverhampton, , United Kingdom

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Countries

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Czechia Denmark Greece Ireland Slovakia Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 29254376 (View on PubMed)

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=223

Link to results on the Astellas Clinical Study Results website.

Other Identifiers

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178-MA-1002

Identifier Type: -

Identifier Source: org_study_id

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