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

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder (OAB)
• Intervention / Treatment: Drug: mirabegron; Drug: darifenacin; Drug: imidafenacin; Drug: tolterodine; Drug: oxybutynin; Drug: trospium; Drug: fesoterodine; Device: solifenacin; Device: propiverine

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 805

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Site KR410008
  • Incheon, Korea, Republic of
    • Site KR410009
  • Kangam, Korea, Republic of
    • Site KR410005
  • Seoul, Korea, Republic of
    • Site KR410001
  • Seoul, Korea, Republic of
    • Site KR410002
  • Seoul, Korea, Republic of
    • Site KR410003
  • Seoul, Korea, Republic of
    • Site KR410006
  • Seoul, Korea, Republic of
    • Site KR410007
  • Suwon, Korea, Republic of
    • Site KR410004
• Taiwan
  • Hualien City, Taiwan
    • Site TW158001
  • Kaohsiung, Taiwan
    • Site TW158006
  • Kaohsiung City, Taiwan
    • Site TW158003
  • Taichung, Taiwan
    • Site TW158002
  • Taipei, Taiwan
    • Site TW158004
  • Taoyuan City, Taiwan
    • Site TW158005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and/or female adult OAB patients, whose physicians have decided to start OAB drug therapy in routine clinical practice.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mirabegron; Participants will commence the OAB treatment with mirabegron that is prescribed by a physician in routine clinical practice.	Drug: mirabegron; oral; Other Names: YM178; Betmiga
Antimuscarinics; 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.	Drug: darifenacin; oral; Drug: imidafenacin; oral; Drug: tolterodine; oral; Drug: oxybutynin; oral; Drug: trospium; oral; Drug: fesoterodine; oral; Device: solifenacin; oral; Other Names: Vesicare; YM905; Device: propiverine; oral

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Singapore Pte. Ltd.
• Investigators: Study Director: Central Contact, Astellas Pharma Singapore Pte. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Overactive Bladder; OAB; YM178; mirabegron; Betmiga
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Oxybutynin; Darifenacin; Mirabegron; Solifenacin Succinate; Tolterodine Tartrate; Fesoterodine; Propiverine
• Other Study ID Numbers: 178-MA-3146

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No