An observational study in Urgency Incontinence, Urinary Bladder Overactive and Overactive Bladder, sponsored by Astellas Pharma Europe Ltd.. Completed at 60 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Astellas Pharma Europe Ltd. (part of Astellas Pharma Inc) · 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.
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
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 863 is above the median of 120 across 169 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Astellas Pharma Europe Ltd. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Secondary care centers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: YM178, Mirabegron, Myrbetriq®, Betanis®
Change from baseline in QoL based on the OAB-q subscales
Quality of life (QoL) based on the Overactive bladder questionnaire (OAB-q) subscales
Time frame: Baseline up to 12 months post-baseline
Change from baseline in patient treatment satisfaction based on TS-VAS
Based on Treatment Satisfaction Visual Analogue Scale (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
QoL based on Work Productivity Activity Index:Specific Health Problem (WPAI:SHP) and EUROQOL 5-DIMENSIONS (EQ5D)
Time frame: 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)
Time frame: 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)
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
Adverse Events (AEs), Adverse Drug Reaction (ADR)
Time frame: 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.
Time frame: Baseline up to 12 months post-baseline
Plan to share: 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/.
Ran from Nov 2014 to primary completion in Jul 2016, 20 months.
Of 59 observational studies under Urinary Bladder, Overactive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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