Urgency IncontinenceBELIEVENCT02320773
A Prospective Non-interventional Study in Overactive Bladder (OAB) Patients Prescribed Betmiga® as Part of Routine Clinical Practice
An observational study of Urgency Incontinence and Urinary Bladder Overactive, run by Astellas Pharma Europe Ltd. at 60 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urgency Incontinence, Urinary Bladder Overactive, Overactive Bladder
- What is being tested?
- Betmiga®
- Type of treatment
- Pill or oral medicine
- How many people
- 863 participants
- Where
- 60 sitesin 8 countries
- Study dates
- 25 Nov 2014to 27 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary care centers
Who may be able to join
- 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.
Who cannot join
- Patients who are currently taking Betmiga®.
- Contraindication(s) as per the Betmiga® Summary of Product Characteristics (SPC).
Trial locations and contacts
60 sites in 8 countries.
60 sites in 8 countries
United Kingdom18 sites
Site GB44005 Bradford Royal Infirmary
Bradford, BD9 6RJ
Site GB44011 Royal Blackburn Hospital
Burnley, BB10 2PQ
Site GB44016 Addenbrookes Hospital
Cambridge, CB2 0QQ
Site GB44009 St. Richards Hospital
Chichester, PO19 6SE
Site GB44007 Northampton General Hospital
Cliftonville, NN1 5BD
Site GB44015 University Hospital Coventry
Coventry, CV2 2DX
Site GB44008 Croydon University Hospital
Croydon, CR7 7YE
Site GB44003 Derriford Hospital
Derriford, PL6 8DH
Site GB44019 Northern Devon Healthcare
Devon, EX31 4JB
Site GB44001 Medway Hospital
Gillingham, ME5 7NY
Site GB44004 Southern General Hospital
Glasgow, G51 4TF
Site GB44013 Hinchingbrooke Hospital
Huntingdon, PE29 6NT
Site GB44010 The Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Site GB44014 The Queen Elizabeth Hospital King's Lynn NHS Trust
Norfolk, PE30 4ET
Site GB44002 The Royal Berkshire Hospital
Reading, RG1 5AN
Site GB44018 Salisbury District Hospital
Salisbury, SP2 8BJ
Site GB44017 Sunderland Royal University Hospital
Sunderland, SR4 7TP
Site GB44006 New Cross Hospital
Wolverhampton, WV10 OQP
Greece11 sites
Site GR30009 PGH Laiko
Athens, 11527
Site GR30001 General Hospital of Athens "Alexandra"
Athens, 11528
Site GR30007 Sismanoglio General Hospital
Athens, 151 26
Site GR30002 University Hospital of Crete
Heraklion, Crete, 71110
Site GR30011 General Hospital of Heraklion 'Venizelio-Pananio'
Heraklion, 71409
Site GR30008 University Hospital of Ioannina
Ioannina, 45445
Site GR30013 University Hospital of Ioannina
Ioannina, 45500
Site GR30005 University Hospital of Larissa
Larissa, 41110
Site GR30003 University Hospital of Patras
Pátrai, 26504
Site GR30006 Papageorgiou General Hospital
Thessaloniki, 56403
Site GR30012 Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56403
Spain11 sites
Site ES34015 Centro Médico Teknon
Barcelona, 08022
Site ES34007 Hospital Universitario Vall D'Hebron
Barcelona, 08035
Site ES34017 Hospital de Mollet
Barcelona
Site ES34020 Hospital Universitario Basurto
Bilbao, 48013
Site ES34009 Hospital Comarcal Santiago Apostol
Burgos, 09200
Site ES34021 H. de Donostia
Donostia / San Sebastian, 20014
Site ES34019 Hospital Universitario Lucus Augusti
Lugo, 27003
Site ES34012 H. de Mendaro
Mendaro, Guipuzcoa, 20850
Site ES34005 Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
Site ES34011 Hospital del Rio Hortega
Valladolid, 47011
Site ES34010 Policlínico de Vigo, S.A.-POVISA
Vigo, 36211
Czechia7 sites
Site CZ42009 UROMEDA s. r. o.
Brno, 615 00
Site CZ42003 Fakultni nemocnice Brno-Bohunice
Brno
Site CZ42006 Hospital Kyjov
Kyjov
Site CZ42002 Fakultni nemocnice Kralovske Vinohrady
Prague
Site CZ42007 MEDICON a.s.
Prague
Site CZ42008 Oblastni nemocnice Pribram
Příbram
Site CZ42004 Krajská nemocnice Tomáše Bati
Zlín
Slovakia7 sites
Site SK42101 Univerzitná nemocnica Bratislava - Kramáre
Bratislava, 833 05
Site SK42106 UROCENTRUM LEVICE, s.r.o.
Levice, 934 01,
Site SK42102 UROAMB, s.r.o.
Liptovský Mikuláš, 03101
Site SK42104 Urologicka ambulancia, Miramed, sro
Rimavská Sobota, 979 01
Site SK42107 Private Urological Care Center
Trenčín
Site SK42103 CMFF, sro
Vranov nad Topľou, 093 01
Site SK42105 ProCare Ziar nad Hronom
Žiar nad Hronom, 965 63
Ireland3 sites
Site IE35302 Coombe Hospital
Dublin
Site IE35303 Kerry General Hospital
Kerry
Site IE35304 Midland Regional Hospital
Mullingar, Co. Westmeath
Denmark2 sites
Site DK45003 Sygehus Vendsyssel, Frederikshavn
Frederikshavn, 9900
Site DK45004 Regionshospitalet Herning
Herning, 7440
About this study
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)
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.
Read the 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
- Conditions
- Urgency Incontinence, Urinary Bladder Overactive, Overactive Bladder, Urologic Diseases, Urinary Bladder Diseases
- Being tested
- Betmiga®
- Keywords
- Overactive Bladder, Quality of Life, Betanis®, Betmiga®, Observational, Myrbetriq®
- Medical subject headings
- Urinary Bladder, Overactive, Urologic Diseases, Urinary Bladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betmiga®Drug
Also called YM178, Mirabegron, Myrbetriq®, Betanis®
Oral
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Betmiga® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QoL based on the OAB-q subscales
Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales
Measured: Baseline up to 12 months post-baseline
Secondary outcomes (7)
Change from baseline in patient treatment satisfaction based on TS-VAS
Based on Treatment Satisfaction Visual Analogue Scale (TS-VAS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From enrollment to end of study (up to 12 months
Change from baseline in incontinence status during the study
Measured: 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)
Measured: 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.
Measured: Baseline up to 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study start25 Nov 2014
- Primary completion27 Jul 2016
- Study completion27 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urgency IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 863 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs Europe, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320773
- Sponsor's protocol ID
- 178-MA-1002
- Acronym
- BELIEVE
- Status last verified
- Oct 2024
- First submitted
- 17 Nov 2014
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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.
PubMed 29254376
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02320773
- Acronym / sponsor ID
- BELIEVE / 178-MA-1002
- Conditions
- Urgency Incontinence, Urinary Bladder Overactive, Overactive Bladder, Urologic Diseases, Urinary Bladder Diseases
- Keywords
- Overactive Bladder, Quality of Life, Betanis®, Betmiga®, Observational, Myrbetriq®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 863 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2014 (actual)
- Primary completion
- 27 Jul 2016 (actual)
- Study completion
- 27 Jul 2016 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. OAB patients taking Betmiga® | – | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care centers
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are currently taking Betmiga®.
- Contraindication(s) as per the Betmiga® Summary of Product Characteristics (SPC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betmiga®Also: YM178, Mirabegron, Myrbetriq®, Betanis®Oral | Drug | 1. OAB patients taking Betmiga® |
Primary outcome
Change from baseline in QoL based on the OAB-q subscales
Time frame: Baseline up to 12 months post-baseline
Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales
7 secondary outcomes
Change from baseline in patient treatment satisfaction based on TS-VAS
Time frame: Baseline up to 12 months post-baseline
Change from baseline in QoL based on the EQ-5D-5L subscales and WPAI:SHP
Time frame: Baseline up to 12 months post-baseline
Summary of utilisation of healthcare resources related to the management of OAB
Time frame: From enrollment to end of study (up to 12 months)
Frequency summary of disease progression
Time frame: From enrollment to end of study (up to 12 months
Change from baseline in incontinence status during the study
Time frame: Baseline up to 12 months post-baseline
Safety assessed by recording of AEs and ADRs during the study
Time frame: From enrollment to end of study (up to 12 months)
Summary of prescription status to assess treatment patterns and persistence with treatment
Time frame: Baseline up to 12 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Derived from this study: PubMed 29254376Freeman 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.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Urgency Incontinence
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Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
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A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
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Sacral Neuromodulation for Male Overactive Bladder (MOAB)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Affairs Europe study director
Astellas Pharma Europe Ltd.
60 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urgency Incontinence and Urinary Bladder Overactive, run by Astellas Pharma Europe Ltd. at 60 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United Kingdom, Greece, Spain, Czechia, Slovakia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in QoL based on the OAB-q subscales (time frame: Baseline up to 12 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.