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)

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.

Study Overview

• Status: Completed
• Conditions: Urologic Diseases; Overactive Bladder; Urinary Bladder Diseases; Urgency Incontinence; Urinary Bladder Overactive
• Intervention / Treatment: Drug: Betmiga®

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

• Study Type: Observational
• Enrollment (Actual): 863

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 615 00
    • Site CZ42009 UROMEDA s. r. o.
  • Brno, Czechia
    • Site CZ42003 Fakultni nemocnice Brno-Bohunice
  • Kyjov, Czechia
    • Site CZ42006 Hospital Kyjov
  • Praha 10, Czechia
    • Site CZ42002 Fakultni nemocnice Kralovske Vinohrady
  • Praha 4, Czechia
    • Site CZ42007 MEDICON a.s.
  • Příbram, Czechia
    • Site CZ42008 Oblastni nemocnice Pribram
  • Zlín, Czechia
    • Site CZ42004 Krajská nemocnice Tomáše Bati
• Denmark
  • Frederikshavn, Denmark, 9900
    • Site DK45003 Sygehus Vendsyssel, Frederikshavn
  • Herning, Denmark, 7440
    • Site DK45004 Regionshospitalet Herning
• Greece
  • Athens, Greece, 11527
    • Site GR30009 PGH Laiko
  • Athens, Greece, 11528
    • Site GR30001 General Hospital of Athens "Alexandra"
  • Athens, Greece, 151 26
    • Site GR30007 Sismanoglio General Hospital
  • Heraklion, Greece, 71409
    • Site GR30011 General Hospital of Heraklion 'Venizelio-Pananio'
  • Ioannina, Greece, 45445
    • Site GR30008 University Hospital of Ioannina
  • Ioannina, Greece, 45500
    • Site GR30013 University Hospital of Ioannina
  • Larisa, Greece, 41110
    • Site GR30005 University Hospital of Larissa
  • Patras, Greece, 26504
    • Site GR30003 University Hospital of Patras
  • Thessaloniki, Greece, 56403
    • Site GR30006 Papageorgiou General Hospital
  • Thessaloniki, Greece, 56403
    • Site GR30012 Papageorgiou General Hospital of Thessaloniki
  • Crete
    • Heraklion, Crete, Greece, 71110
      • Site GR30002 University Hospital of Crete
• Ireland
  • Dublin 8, Ireland
    • Site IE35302 Coombe Hospital
  • Kerry, Ireland
    • Site IE35303 Kerry General Hospital
  • Co. Westmeath
    • Mullingar, Co. Westmeath, Ireland
      • Site IE35304 Midland Regional Hospital
• Slovakia
  • Bratislava 3, Slovakia, 833 05
    • Site SK42101 Univerzitná nemocnica Bratislava - Kramáre
  • Levice, Slovakia, 934 01,
    • Site SK42106 UROCENTRUM LEVICE, s.r.o.
  • Liptovský Mikuláš, Slovakia, 03101
    • Site SK42102 UROAMB, s.r.o.
  • Rimavská Sobota, Slovakia, 979 01
    • Site SK42104 Urologicka ambulancia, Miramed, sro
  • Trenčín, Slovakia
    • Site SK42107 Private Urological Care Center
  • Vranov Nad Topľou, Slovakia, 093 01
    • Site SK42103 CMFF, sro
  • Žiar Nad Hronom, Slovakia, 965 63
    • Site SK42105 ProCare Ziar nad Hronom
• Spain
  • Barcelona, Spain, 08022
    • Site ES34015 Centro Médico Teknon
  • Barcelona, Spain, 08035
    • Site ES34007 Hospital Universitario Vall D'Hebron
  • Barcelona, Spain
    • Site ES34017 Hospital de Mollet
  • Bilbao, Spain, 48013
    • Site ES34020 Hospital Universitario Basurto
  • Burgos, Spain, 09200
    • Site ES34009 Hospital Comarcal Santiago Apostol
  • Lugo, Spain, 27003
    • Site ES34019 Hospital Universitario Lucus Augusti
  • San Sebastian, Spain, 20014
    • Site ES34021 H. de Donostia
  • Valladolid, Spain, 47011
    • Site ES34011 Hospital del Rio Hortega
  • Vigo, Spain, 36211
    • Site ES34010 Policlínico de Vigo, S.A.-POVISA
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Site ES34005 Corporació Sanitaria Parc Taulí
  • Guipuzcoa
    • Mendaro, Guipuzcoa, Spain, 20850
      • Site ES34012 H. de Mendaro
• Sweden
  • Göteborg, Sweden, 412 55
    • Site SE46002 Urologkliniken Carlanderska
• United Kingdom
  • Bradford, United Kingdom, BD9 6RJ
    • Site GB44005 Bradford Royal Infirmary
  • Burnley, United Kingdom, BB10 2PQ
    • Site GB44011 Royal Blackburn Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Site GB44016 Addenbrookes Hospital
  • Chichester, United Kingdom, PO19 6SE
    • Site GB44009 St. Richards Hospital
  • Cliftonville, United Kingdom, NN1 5BD
    • Site GB44007 Northampton General Hospital
  • Coventry, United Kingdom, CV2 2DX
    • Site GB44015 University Hospital Coventry
  • Croydon, United Kingdom, CR7 7YE
    • Site GB44008 Croydon University Hospital
  • Derriford, United Kingdom, PL6 8DH
    • Site GB44003 Derriford Hospital
  • Devon, United Kingdom, EX31 4JB
    • Site GB44019 Northern Devon Healthcare
  • Gillingham, United Kingdom, ME5 7NY
    • Site GB44001 Medway Hospital
  • Glasgow, United Kingdom, G51 4TF
    • Site GB44004 Southern General Hospital
  • Huntingdon, United Kingdom, PE29 6NT
    • Site GB44013 Hinchingbrooke Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Site GB44010 The Freeman Hospital
  • Norfolk, United Kingdom, PE30 4ET
    • Site GB44014 The Queen Elizabeth Hospital King's Lynn NHS Trust
  • Reading, United Kingdom, RG1 5AN
    • Site GB44002 The Royal Berkshire Hospital
  • Salisbury, United Kingdom, SP2 8BJ
    • Site GB44018 Salisbury District Hospital
  • Sunderland, United Kingdom, SR4 7TP
    • Site GB44017 Sunderland Royal University Hospital
  • Wolverhampton, United Kingdom, WV10 OQP
    • Site GB44006 New Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Secondary care centers

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Betmiga®; Oral; Other Names: YM178; Mirabegron; Myrbetriq®; Betanis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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: Number and percentage of patients who switched treatment, and to what treatment they were switched.; Number and percentage of patients who stopped treatment and reasons associated with discontinuation.; Number of treatment days on current treatment.; Time from treatment initiation to discontinuation or switching to another treatment.; Time from treatment initiation to prescription of additional oral OAB treatment and reasons for combination treatment.	Baseline up to 12 months post-baseline

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.
• Investigators: Study Director: Medical Affairs Europe, Astellas Pharma Europe Ltd.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Link to results on the Astellas Clinical Study Results website.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2014
• Primary Completion (Actual): July 27, 2016
• Study Completion (Actual): July 27, 2016

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Life; Observational; Overactive Bladder; Betanis®; Betmiga®; Myrbetriq®
• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Urologic Diseases; Urinary Bladder Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron
• Other Study ID Numbers: 178-MA-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."