A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)

Study Overview
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Brief Summary
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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)

Official Title
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A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)

Conditions
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Urinary Bladder Overactive, Overactive Bladder, Urinary Bladder Diseases, Urologic Diseases

Intervention / Treatment
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* Drug: mirabegron
* Drug: antimuscarinic medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. patients diagnosed with OAB taking mirabegron<br>patients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice | Drug: mirabegron<br>* oral<br>* Other names: Betmiga;|
| 2. patients diagnosed with OAB taking an antimuscarinic<br>patients diagnosed with OAB whose physician has decided to prescribe an antimuscarinic as part of routine clinical practice | Drug: antimuscarinic medication<br>* oral<br>* Other names: Detrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in OAB-related QoL and symptom bother | Overactive Bladder (OAB), Quality of Life (QoL). As measured by the Overactive Bladder Questionnaire Short Form (OAB-Q-SF) questionnaire scores | Baseline, Month 1, 3, 6 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness as measured by impression of severity of OAB | Via the Patient Perception of Bladder Condition [PPBC] | Baseline, Month 1, 3, 6 and 12 | 
| Effectiveness as measured by general health related QoL | via the EuroQol 5D [EQ-5D] | Baseline, Month 1, 3, 6 and 12 | 
| Persistence with OAB drug treatment | The duration of time a patient continues to take the prescribed medication | Baseline till End of Study (ESV) (up to month 12) | 
| Use of additional (add-on) medications | As reported by patients and HCP | Baseline till ESV (up to month 12) | 
| Switching of medication | As reported by patients and HCP | Baseline till ESV (up to month 12) | 
| OAB drug treatment satisfaction | Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S) | Baseline, month 1, 3, 6 and 12 | 
| Reasons for switching of medication | As reported by patients and HCP for each specific medication, number and percent | Baseline till ESV (up to month 12) | 
| Reasons for discontinuation of medication | As reported by patients and HCP for each specific medication, number and percent | Baseline till ESV (up to month 12) | 
| Reasons for add-on medication | As reported by patients and HCP for each specific medication, number and percent | Baseline till ESV (up to month 12) | 
| Reasons for dose titration | As reported by patients and HCP for each specific medication | Baseline till ESV (up to month 12) | 
| Frequency of dose titration | As reported by patients and HCP for each specific medication | Baseline till ESV (up to month 12) | 
| Safety profile as assessed by recording AEs and SAEs | Adverse Events (AEs), Serious Adverse Events (SAEs) | Baseline till ESV (up to month 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Betanis®, Myrbetriq®, Quality of Life, Antimuscarinics, Betmiga®, Overactive Bladder, Observational