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

Sponsor

Astellas Pharma Singapore Pte. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03572231

Collaborator

(none)

805

Enrollment

Locations

20.4

Actual Duration (Months)

53.7

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder (OAB)	Drug: mirabegron Device: solifenacin Drug: darifenacin Drug: imidafenacin Drug: tolterodine Drug: oxybutynin Drug: trospium Drug: fesoterodine 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 Design

Study Type:

Observational

Actual Enrollment :

805 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 19, 2018

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Mar 30, 2020

Arms and Interventions

Arm	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.	Device: solifenacin oral Other Names: YM905 Vesicare Drug: darifenacin oral Drug: imidafenacin oral Drug: tolterodine oral Drug: oxybutynin oral Drug: trospium oral Drug: fesoterodine oral Device: propiverine oral

Arm

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.

Device: solifenacin

oral

Other Names:

YM905

Vesicare

Drug: darifenacin

oral

Drug: imidafenacin

oral

Drug: tolterodine

oral

Drug: oxybutynin

oral

Drug: trospium

oral

Drug: fesoterodine

oral

Device: propiverine

oral

Outcome Measures

Primary Outcome Measures

Time from treatment initiation to discontinuation of Overactive Bladder (OAB) therapy [Up to 26 weeks]
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).
Time from treatment initiation to switching to another OAB therapy or dose [Up to 26 weeks]
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.
Proportion of participants who discontinue OAB treatment [Up to 26 weeks]
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).
Proportion of participants who switch to another treatment or dose [Up to 26 weeks]
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.

Secondary Outcome Measures

Change from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score [Baseline, weeks 10-14 and weeks 22-26]
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.
Change from baseline in Bladder Assessment Tool (BAT) score [Baseline, weeks 10-14 and weeks 22-26]
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.
Change from baseline in Overactive Bladder Symptom Scores (OABSS) score [Baseline, weeks 10-14 and weeks 22-26]
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.
Change from baseline in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score [Baseline, weeks 10-14 and weeks 22-26]
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.
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Demographic Information [Baseline (up to Day 0)]
Demographic information will be collected from participants for analysis.
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: OAB Medical History [Baseline (up to Day 0)]
OAB medical history will be collected from participants for analysis.
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: History of prior drug treatment for OAB [Baseline (up to Day 0)]
History of prior drug treatment for OAB will be collected from participants for analysis.
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Medical history [Baseline (up to Day 0)]
Medical history will be collected from participants for analysis.
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medication information [Up to 26 weeks]
Concomitant medication will be collected from participants for analysis.
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medical conditions [Up to 26 weeks]
Participants medical history will be collected from participants for analysis.
Health Care Resource Utilization (HCRU) related to the management of OAB [Up to 26 weeks]
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.
Safety assessed by Adverse Events (AEs) [Up to 26 weeks]
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.
Safety assessed by Serious Adverse Events (SAEs) [Up to 26 weeks]
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.
Safety assessed by Adverse Drug Reaction (ADR) [Up to 26 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Site KR410008	Daejeon	Korea, Republic of
2	Site KR410009	Incheon	Korea, Republic of
3	Site KR410005	Kangam	Korea, Republic of
4	Site KR410001	Seoul	Korea, Republic of
5	Site KR410002	Seoul	Korea, Republic of
6	Site KR410003	Seoul	Korea, Republic of
7	Site KR410006	Seoul	Korea, Republic of
8	Site KR410007	Seoul	Korea, Republic of
9	Site KR410004	Suwon	Korea, Republic of
10	Site TW158001	Hualien City	Taiwan
11	Site TW158003	Kaohsiung City	Taiwan
12	Site TW158006	Kaohsiung	Taiwan
13	Site TW158002	Taichung	Taiwan
14	Site TW158004	Taipei	Taiwan
15	Site TW158005	Taoyuan City	Taiwan