Overactive Bladder Clinical Trial
— BELIEVEOfficial 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)
| NCT number | NCT02320773 |
| Other study ID # | 178-MA-1002 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 25, 2014 |
| Est. completion date | July 27, 2016 |
| Verified date | February 2019 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 863 |
| Est. completion date | July 27, 2016 |
| Est. primary completion date | July 27, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Site CZ42003 Fakultni nemocnice Brno-Bohunice | Brno | |
| Czechia | Site CZ42009 UROMEDA s. r. o. | Brno | |
| Czechia | Site CZ42006 Hospital Kyjov | Kyjov | |
| Czechia | Site CZ42002 Fakultni nemocnice Kralovske Vinohrady | Praha 10 | |
| Czechia | Site CZ42007 MEDICON a.s. | Praha 4 | |
| Czechia | Site CZ42008 Oblastni nemocnice Pribram | Príbram | |
| Czechia | Site CZ42004 Krajská nemocnice Tomáše Bati | Zlín | |
| Denmark | Site DK45003 Sygehus Vendsyssel, Frederikshavn | Frederikshavn | |
| Denmark | Site DK45004 Regionshospitalet Herning | Herning | |
| Greece | Site GR30001 General Hospital of Athens "Alexandra" | Athens | |
| Greece | Site GR30007 Sismanoglio General Hospital | Athens | |
| Greece | Site GR30009 PGH Laiko | Athens | |
| Greece | Site GR30002 University Hospital of Crete | Heraklion | Crete |
| Greece | Site GR30011 General Hospital of Heraklion 'Venizelio-Pananio' | Heraklion | |
| Greece | Site GR30008 University Hospital of Ioannina | Ioannina | |
| Greece | Site GR30013 University Hospital of Ioannina | Ioannina | |
| Greece | Site GR30005 University Hospital of Larissa | Larisa | |
| Greece | Site GR30003 University Hospital of Patras | Patras | |
| Greece | Site GR30006 Papageorgiou General Hospital | Thessaloniki | |
| Greece | Site GR30012 Papageorgiou General Hospital of Thessaloniki | Thessaloniki | |
| Ireland | Site IE35302 Coombe Hospital | Dublin 8 | |
| Ireland | Site IE35303 Kerry General Hospital | Kerry | |
| Ireland | Site IE35304 Midland Regional Hospital | Mullingar | Co. Westmeath |
| Slovakia | Site SK42105 ProCare Ziar nad Hronom | Žiar Nad Hronom | |
| Slovakia | Site SK42101 Univerzitná nemocnica Bratislava - Kramáre | Bratislava 3 | |
| Slovakia | Site SK42106 UROCENTRUM LEVICE, s.r.o. | Levice | |
| Slovakia | Site SK42102 UROAMB, s.r.o. | Liptovský Mikuláš | |
| Slovakia | Site SK42104 Urologicka ambulancia, Miramed, sro | Rimavská Sobota | |
| Slovakia | Site SK42107 Private Urological Care Center | Trencín | |
| Slovakia | Site SK42103 CMFF, sro | Vranov Nad Toplou | |
| Spain | Site ES34007 Hospital Universitario Vall D'Hebron | Barcelona | |
| Spain | Site ES34015 Centro Médico Teknon | Barcelona | |
| Spain | Site ES34017 Hospital de Mollet | Barcelona | |
| Spain | Site ES34020 Hospital Universitario Basurto | Bilbao | |
| Spain | Site ES34009 Hospital Comarcal Santiago Apostol | Burgos | |
| Spain | Site ES34019 Hospital Universitario Lucus Augusti | Lugo | |
| Spain | Site ES34012 H. de Mendaro | Mendaro | Guipuzcoa |
| Spain | Site ES34005 Corporació Sanitaria Parc Taulí | Sabadell | Barcelona |
| Spain | Site ES34021 H. de Donostia | San Sebastian | |
| Spain | Site ES34011 Hospital del Rio Hortega | Valladolid | |
| Spain | Site ES34010 Policlínico de Vigo, S.A.-POVISA | Vigo | |
| Sweden | Site SE46002 Urologkliniken Carlanderska | Göteborg | |
| United Kingdom | Site GB44005 Bradford Royal Infirmary | Bradford | |
| United Kingdom | Site GB44011 Royal Blackburn Hospital | Burnley | |
| United Kingdom | Site GB44016 Addenbrookes Hospital | Cambridge | |
| United Kingdom | Site GB44009 St. Richards Hospital | Chichester | |
| United Kingdom | Site GB44007 Northampton General Hospital | Cliftonville | |
| United Kingdom | Site GB44015 University Hospital Coventry | Coventry | |
| United Kingdom | Site GB44008 Croydon University Hospital | Croydon | |
| United Kingdom | Site GB44003 Derriford Hospital | Derriford | |
| United Kingdom | Site GB44019 Northern Devon Healthcare | Devon | |
| United Kingdom | Site GB44001 Medway Hospital | Gillingham | |
| United Kingdom | Site GB44004 Southern General Hospital | Glasgow | |
| United Kingdom | Site GB44013 Hinchingbrooke Hospital | Huntingdon | |
| United Kingdom | Site GB44010 The Freeman Hospital | Newcastle upon Tyne | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Europe Ltd. |
Czechia, Denmark, Greece, Ireland, Slovakia, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | Change from baseline in incontinence status during the study | Baseline up to 12 months post-baseline | ||
| Secondary | 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) | |
| Secondary | 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 |
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