A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice
- Conditions
- Urgency IncontinenceUrinary Bladder OveractiveOveractive BladderUrologic DiseasesUrinary Bladder Diseases
- Interventions
- Registration Number
- NCT02320773
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 863
- 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.
- Patients who are currently taking Betmiga®.
- Contraindication(s) as per the Betmiga® Summary of Product Characteristics (SPC).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1. OAB patients taking Betmiga® 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
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)
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)
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)
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 From enrollment to end of study (up to 12 months) Adverse Events (AEs), Adverse Drug Reaction (ADR)
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.
Trial Locations
- Locations (60)
Site SK42103 CMFF, sro
🇸🇰Vranov Nad Topľou, Slovakia
Site SK42105 ProCare Ziar nad Hronom
🇸🇰Žiar Nad Hronom, Slovakia
Site GR30012 Papageorgiou General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Site IE35303 Kerry General Hospital
🇮🇪Kerry, Ireland
Site GR30013 University Hospital of Ioannina
🇬🇷Ioannina, Greece
Site GB44005 Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Site CZ42008 Oblastni nemocnice Pribram
🇨🇿Příbram, Czechia
Site CZ42004 Krajská nemocnice Tomáše Bati
🇨🇿Zlín, Czechia
Site GR30002 University Hospital of Crete
🇬🇷Heraklion, Crete, Greece
Site ES34005 Corporació Sanitaria Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Site CZ42002 Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Site ES34015 Centro Médico Teknon
🇪🇸Barcelona, Spain
Site GR30007 Sismanoglio General Hospital
🇬🇷Athens, Greece
Site GR30008 University Hospital of Ioannina
🇬🇷Ioannina, Greece
Site SE46002 Urologkliniken Carlanderska
🇸🇪Göteborg, Sweden
Site ES34012 H. de Mendaro
🇪🇸Mendaro, Guipuzcoa, Spain
Site SK42102 UROAMB, s.r.o.
🇸🇰Liptovský Mikuláš, Slovakia
Site SK42107 Private Urological Care Center
🇸🇰Trenčín, Slovakia
Site GR30009 PGH Laiko
🇬🇷Athens, Greece
Site GR30001 General Hospital of Athens "Alexandra"
🇬🇷Athens, Greece
Site GR30006 Papageorgiou General Hospital
🇬🇷Thessaloniki, Greece
Site CZ42007 MEDICON a.s.
🇨🇿Praha 4, Czechia
Site CZ42003 Fakultni nemocnice Brno-Bohunice
🇨🇿Brno, Czechia
Site CZ42006 Hospital Kyjov
🇨🇿Kyjov, Czechia
Site SK42106 UROCENTRUM LEVICE, s.r.o.
🇸🇰Levice, Slovakia
Site SK42104 Urologicka ambulancia, Miramed, sro
🇸🇰Rimavská Sobota, Slovakia
Site ES34020 Hospital Universitario Basurto
🇪🇸Bilbao, Spain
Site DK45003 Sygehus Vendsyssel, Frederikshavn
🇩🇰Frederikshavn, Denmark
Site DK45004 Regionshospitalet Herning
🇩🇰Herning, Denmark
Site GB44009 St. Richards Hospital
🇬🇧Chichester, United Kingdom
Site ES34007 Hospital Universitario Vall D'Hebron
🇪🇸Barcelona, Spain
Site ES34009 Hospital Comarcal Santiago Apostol
🇪🇸Burgos, Spain
Site ES34021 H. de Donostia
🇪🇸San Sebastian, Spain
Site CZ42009 UROMEDA s. r. o.
🇨🇿Brno, Czechia
Site GR30011 General Hospital of Heraklion 'Venizelio-Pananio'
🇬🇷Heraklion, Greece
Site IE35304 Midland Regional Hospital
🇮🇪Mullingar, Co. Westmeath, Ireland
Site IE35302 Coombe Hospital
🇮🇪Dublin 8, Ireland
Site GR30005 University Hospital of Larissa
🇬🇷Larisa, Greece
Site GR30003 University Hospital of Patras
🇬🇷Patras, Greece
Site SK42101 Univerzitná nemocnica Bratislava - Kramáre
🇸🇰Bratislava 3, Slovakia
Site ES34010 Policlínico de Vigo, S.A.-POVISA
🇪🇸Vigo, Spain
Site GB44016 Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Site GB44011 Royal Blackburn Hospital
🇬🇧Burnley, United Kingdom
Site GB44007 Northampton General Hospital
🇬🇧Cliftonville, United Kingdom
Site GB44008 Croydon University Hospital
🇬🇧Croydon, United Kingdom
Site GB44015 University Hospital Coventry
🇬🇧Coventry, United Kingdom
Site GB44019 Northern Devon Healthcare
🇬🇧Devon, United Kingdom
Site GB44003 Derriford Hospital
🇬🇧Derriford, United Kingdom
Site GB44001 Medway Hospital
🇬🇧Gillingham, United Kingdom
Site GB44004 Southern General Hospital
🇬🇧Glasgow, United Kingdom
Site GB44010 The Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Site GB44013 Hinchingbrooke Hospital
🇬🇧Huntingdon, United Kingdom
Site GB44014 The Queen Elizabeth Hospital King's Lynn NHS Trust
🇬🇧Norfolk, United Kingdom
Site GB44002 The Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
Site GB44018 Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
Site GB44017 Sunderland Royal University Hospital
🇬🇧Sunderland, United Kingdom
Site GB44006 New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Site ES34019 Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Site ES34011 Hospital del Rio Hortega
🇪🇸Valladolid, Spain
Site ES34017 Hospital de Mollet
🇪🇸Barcelona, Spain