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

Sponsor
Astellas Pharma Europe Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02320773
Collaborator
(none)
863
Enrollment
60
Locations
20
Actual Duration (Months)
14.4
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
863 participants
Observational Model:
Other
Time Perspective:
Prospective
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)
Actual Study Start Date :
Nov 25, 2014
Actual Primary Completion Date :
Jul 27, 2016
Actual Study Completion Date :
Jul 27, 2016

Arms and Interventions

Arm 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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in QoL based on the OAB-q subscales [Baseline up to 12 months post-baseline]

      Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales

    Secondary Outcome Measures

    1. Change from baseline in patient treatment satisfaction based on TS-VAS [Baseline up to 12 months post-baseline]

      Based on Treatment Satisfaction Visual Analogue Scale (TS-VAS)

    2. Change from baseline in QoL based on the EQ-5D-5L subscales and WPAI:SHP [Baseline up to 12 months post-baseline]

      QoL based on Work Productivity Activity Index:Specific Health Problem (WPAI:SHP) and EUROQOL 5-DIMENSIONS (EQ5D)

    3. Summary of utilisation of healthcare resources related to the management of OAB [From enrollment to end of study (up to 12 months)]

      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)

    4. Frequency summary of disease progression [From enrollment to end of study (up to 12 months]

      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)

    5. Change from baseline in incontinence status during the study [Baseline up to 12 months post-baseline]

    6. Safety assessed by recording of AEs and ADRs during the study [From enrollment to end of study (up to 12 months)]

      Adverse Events (AEs), Adverse Drug Reaction (ADR)

    7. Summary of prescription status to assess treatment patterns and persistence with treatment [Baseline up to 12 months post-baseline]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Astellas Pharma Europe Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Europe Ltd.
    ClinicalTrials.gov Identifier:
    NCT02320773
    Other Study ID Numbers:
    • 178-MA-1002
    First Posted:
    Dec 19, 2014
    Last Update Posted:
    Feb 15, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Astellas Pharma Europe Ltd.
    Overactive Bladder
    Quality of Life
    Betanis®
    Betmiga®
    Observational
    Myrbetriq®
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Urologic Diseases
    Urinary Bladder Diseases
    Mirabegron

    Study Results

    No Results Posted as of Feb 15, 2019