A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

Study Overview
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Brief Summary
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The purpose of this study is to observe and describe treatment patterns, like Overactive Bladder (OAB) treatment discontinuation, switching to other therapies and persistence of OAB therapies in routine clinical practice. This study will also evaluate effectiveness of OAB therapies in routine clinical practice; identify factors associated with effectiveness and persistence of pharmacologic therapies in OAB participants; evaluate the Quality of Life (QoL) and treatment satisfaction of OAB therapies; as well as evaluate health care resource utilization (HCRU) and understand adverse events (AEs), serious adverse events (SAEs) and adverse drug reactions (ADRs) associated with OAB therapies.

Detailed Description
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This is an observational registry study and will not provide or recommend any treatment; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with the treating physician's usual practices and all eligible participants will be enrolled in a certain timeframe. OAB participants enrolled in the study will be categorized into one of two treatment groups, but the study does not plan to compare the two treatment groups.

Official Title
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A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China

Conditions
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Overactive Bladder (OAB)

Intervention / Treatment
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* Drug: mirabegron
* Device: solifenacin
* Drug: darifenacin
* Drug: imidafenacin
* Drug: tolterodine
* Drug: oxybutynin
* Drug: trospium
* Drug: fesoterodine
* Device: propiverine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with OAB symptoms (with or without urgency incontinence) with symptoms for at least three months prior to study enrollment. About to initiate monotherapy of mirabegron or any antimuscarinics therapy for OAB symptoms, prescribed as part of routine clinical practice, which maybe the first course of any treatment for OAB, lapsed of treatment, or switching from one drug to another. Exclusion Criteria: Currently receiving more than one medication (including Chinese herbal medicine) for OAB. Current participation in clinical trials of OAB. Have undergone surgery for OAB in the past. Mixed incontinence where stress incontinence is the predominant form. OAB has been treated with onabotulinum toxin A, sacral neuromodulation, percutaneous tibial nerve stimulation, external beam radiation (XRT), stents, surgery, or intermittent catheterization prior to or at time of enrollment. At risk of Acute Urinary Retention (AUR). Neurologic conditions associated with OAB symptoms. Hypersensitivity and contraindication(s) to mirabegron and antimuscarinics.

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 |
| --- | --- |
| mirabegron<br>Participants will commence the OAB treatment with mirabegron that is prescribed by a physician in routine clinical practice. | Drug: mirabegron<br>* oral<br>* Other names: Betmiga;|
| Antimuscarinics<br>Participants will commence the OAB treatment with one of the following antimuscarinics: solifenacin, darifenacin, imidafenacin, tolterodine, oxybutynin, trospium, fesoterodine or propiverine. The antimuscarinic is prescribed by a physician in routine clinical practice. | Device: solifenacin<br>* oral<br>* Other names: Vesicare;Drug: darifenacin<br>* oral<br>Drug: imidafenacin<br>* oral<br>Drug: tolterodine<br>* oral<br>Drug: oxybutynin<br>* oral<br>Drug: trospium<br>* oral<br>Drug: fesoterodine<br>* oral<br>Device: propiverine<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from treatment initiation to discontinuation of Overactive Bladder (OAB) therapy | Discontinuation will include participants who discontinue mirabegron or antimuscarinics for more than 30 days (defined as the day after the last day of the prior supply to the next dispensing date). | Up to 26 weeks | 
| Time from treatment initiation to switching to another OAB therapy or dose | Switching will be defined as a subset of initial mirabegron or antimuscarinics discontinuers who initiated another/different therapy(ies) within the follow-up period or within 30 days of being prescribed the first treatment. Change of treatment to another formulation of the same drug type under the same dosage will not be considered as switching. | Up to 26 weeks | 
| Proportion of participants who discontinue OAB treatment | Discontinuation will include participants who discontinue mirabegron or antimuscarinics for more than 30 days (defined as the day after the last day of the prior supply to the next dispensing date). | Up to 26 weeks | 
| Proportion of participants who switch to another treatment or dose | Switching will be defined as a subset of initial mirabegron or antimuscarinics discontinuers who initiated another/different therapy(ies) within the follow-up period or within 30 days of being prescribed the first treatment. Change of treatment to another formulation of the same drug type under the same dosage will not be considered as switching. | Up to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score | Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) is a participant-reported instrument consisting of 19 items that assess the degree to which a participant is bothered by OAB symptoms, and the degree of impact of OAB symptoms on daily life. Participants rate each item using a 6-point Likert Scale ranging from Not at all to A very great deal for the symptom bother items and none of the time to All of the time for the Health Related Quality of Life (HRQL) items. | Baseline, weeks 10-14 and weeks 22-26 | 
| Change from baseline in Bladder Assessment Tool (BAT) score | Bladder Assessment Tool (BAT) is a participant-reported instrument consisting of 17 questions regarding the symptoms, bothering, impacts and treatment satisfaction in the past 7 days. Scores range from 0 to 88, a reduction in BAT score indicates an improvement. | Baseline, weeks 10-14 and weeks 22-26 | 
| Change from baseline in Overactive Bladder Symptom Scores (OABSS) score | Overactive Bladder Symptom Scores (OABSS) is a participant-reported instrument consisting of 4 questions regarding daytime frequency, nocturia, urgency, and urgency incontinence; evaluates relevant symptoms from the participant's viewpoint. Scores range from 0 to 15 with a lower score indicating a mild presentation of overactive bladder syndrome and a higher score indicating moderate to severe presentation of overactive bladder syndrome. | Baseline, weeks 10-14 and weeks 22-26 | 
| Change from baseline in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score | Treatment Satisfaction-Visual Analog Scale (TS-VAS) is a quantitative instrument assessing participant improvement in participants with OAB. A score of 10 on the TS-VAS indicates complete satisfaction, whereas a positive change from baseline indicates improvement. | Baseline, weeks 10-14 and weeks 22-26 | 
| Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Demographic Information | Demographic information will be collected from participants for analysis. | Baseline (up to Day 0) | 
| Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: OAB Medical History | OAB medical history will be collected from participants for analysis. | Baseline (up to Day 0) | 
| Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: History of prior drug treatment for OAB | History of prior drug treatment for OAB will be collected from participants for analysis. | Baseline (up to Day 0) | 
| Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Medical history | Medical history will be collected from participants for analysis. | Baseline (up to Day 0) | 
| Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medication information | Concomitant medication will be collected from participants for analysis. | Up to 26 weeks | 
| Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medical conditions | Participants medical history will be collected from participants for analysis. | Up to 26 weeks | 
| Health Care Resource Utilization (HCRU) related to the management of OAB | Participant information will be collected by the investigator or designee via the Healthcare Resource Utilization (HCRU) Worksheet at each visit and the data will be retrieved electronically via the electronic case report form (eCRF). The HCRU worksheet consists of 7 questions related to the participants history and treatment of OAB. | Up to 26 weeks | 
| Safety assessed by Adverse Events (AEs) | An AE is any untoward medical occurrence in a patient or clinical study patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a product, whether or not considered related to the product. Pre-existing conditions that worsen during a study are to be reported as AEs. | Up to 26 weeks | 
| Safety assessed by Serious Adverse Events (SAEs) | Adverse event (AE) is considered serious if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. | Up to 26 weeks | 
| Safety assessed by Adverse Drug Reaction (ADR) | An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship (drug-event) is at least a reasonable possibility. | Up to 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Betmiga, OAB, YM178, Overactive Bladder, mirabegron