Overactive Bladder, Urinary Bladder Diseases, Urinary Bladder Overactive, Urologic Diseases
Conditions
Keywords
Betanis®, Myrbetriq®, Quality of Life, Antimuscarinics, Betmiga®, Overactive Bladder, Observational
Brief summary
A study to identify factors that are associated with improved effectiveness in pharmacologic therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF (Overactive Bladder Questionnaire Short Form)
Interventions
DRUGmirabegron
oral
DRUGantimuscarinic medication
oral
Sponsors
Astellas Scientific & Medical Affairs, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with OAB (with or without urgency incontinence) by the treating HCP, with symptoms for at least three months prior to study enrollment * Initiating a new course of treatment with mirabegron or antimuscarinic medication (including patch formulation) for OAB, which may be first course of any treatment for OAB, restart or switch from one drug to another * Willing and able to complete PRO questionnaires with minimal assistance
Exclusion criteria
* Current participation in clinical trials of OAB * Use of more than one OAB medication at time of enrollment * Patients whose OAB has been treated with onabotulinumtoxinA, sacral neuromodulation, percutaneous tibial nerve stimulation, external beam radiation (XRT), stents, surgery, or intermittent catheterization prior to or at time of enrollment * Neurologic conditions associated with OAB symptoms * Patients residing in a nursing home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in OAB-related QoL and symptom bother | Baseline, Month 1, 3, 6 and 12 | Overactive Bladder (OAB), Quality of Life (QoL). As measured by the Overactive Bladder Questionnaire Short Form (OAB-Q-SF) questionnaire scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness as measured by general health related QoL | Baseline, Month 1, 3, 6 and 12 | via the EuroQol 5D \[EQ-5D\] |
| Persistence with OAB drug treatment | Baseline till End of Study (ESV) (up to month 12) | The duration of time a patient continues to take the prescribed medication |
| Use of additional (add-on) medications | Baseline till ESV (up to month 12) | As reported by patients and HCP |
| Switching of medication | Baseline till ESV (up to month 12) | As reported by patients and HCP |
| OAB drug treatment satisfaction | Baseline, month 1, 3, 6 and 12 | Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S) |
| Effectiveness as measured by impression of severity of OAB | Baseline, Month 1, 3, 6 and 12 | Via the Patient Perception of Bladder Condition \[PPBC\] |
| Reasons for discontinuation of medication | Baseline till ESV (up to month 12) | As reported by patients and HCP for each specific medication, number and percent |
| Reasons for add-on medication | Baseline till ESV (up to month 12) | As reported by patients and HCP for each specific medication, number and percent |
| Reasons for dose titration | Baseline till ESV (up to month 12) | As reported by patients and HCP for each specific medication |
| Frequency of dose titration | Baseline till ESV (up to month 12) | As reported by patients and HCP for each specific medication |
| Safety profile as assessed by recording AEs and SAEs | Baseline till ESV (up to month 12) | Adverse Events (AEs), Serious Adverse Events (SAEs) |
| Reasons for switching of medication | Baseline till ESV (up to month 12) | As reported by patients and HCP for each specific medication, number and percent |
Countries
Canada, United States
Outcome results
None listed