Overactive Bladder, Urgency Incontinence, Urinary Bladder Diseases, Urinary Bladder Overactive, Urologic Diseases
Conditions
Keywords
Overactive Bladder, Quality of Life, Betanis®, Betmiga®, Observational, Myrbetriq®
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
Interventions
DRUGBetmiga®
Oral
Sponsors
Astellas Pharma Europe Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 patient treatment satisfaction based on TS-VAS | Baseline up to 12 months post-baseline | Based on Treatment Satisfaction Visual Analogue Scale (TS-VAS) |
| 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. |
| Change from baseline in incontinence status during the study | Baseline up to 12 months post-baseline | — |
Countries
Czechia, Denmark, Greece, Ireland, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed