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

NCT ID: NCT03572231

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

805 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-19

Study Completion Date

2020-03-30

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.

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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.

Conditions

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Overactive Bladder (OAB)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mirabegron

Participants will commence the OAB treatment with mirabegron that is prescribed by a physician in routine clinical practice.

mirabegron

Intervention Type DRUG

oral

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.

solifenacin

Intervention Type DEVICE

oral

darifenacin

Intervention Type DRUG

oral

imidafenacin

Intervention Type DRUG

oral

tolterodine

Intervention Type DRUG

oral

oxybutynin

Intervention Type DRUG

oral

trospium

Intervention Type DRUG

oral

fesoterodine

Intervention Type DRUG

oral

propiverine

Intervention Type DEVICE

oral

Interventions

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mirabegron

oral

Intervention Type DRUG

solifenacin

oral

Intervention Type DEVICE

darifenacin

oral

Intervention Type DRUG

imidafenacin

oral

Intervention Type DRUG

tolterodine

oral

Intervention Type DRUG

oxybutynin

oral

Intervention Type DRUG

trospium

oral

Intervention Type DRUG

fesoterodine

oral

Intervention Type DRUG

propiverine

oral

Intervention Type DEVICE

Other Intervention Names

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YM178 Betmiga YM905 Vesicare

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Singapore Pte. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Singapore Pte. Ltd.

Locations

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Site KR410008

Daejeon, , South Korea

Site Status

Site KR410009

Incheon, , South Korea

Site Status

Site KR410005

Kangam, , South Korea

Site Status

Site KR410001

Seoul, , South Korea

Site Status

Site KR410002

Seoul, , South Korea

Site Status

Site KR410003

Seoul, , South Korea

Site Status

Site KR410006

Seoul, , South Korea

Site Status

Site KR410007

Seoul, , South Korea

Site Status

Site KR410004

Suwon, , South Korea

Site Status

Site TW158001

Hualien City, , Taiwan

Site Status

Site TW158003

Kaohsiung City, , Taiwan

Site Status

Site TW158006

Kaohsiung City, , Taiwan

Site Status

Site TW158002

Taichung, , Taiwan

Site Status

Site TW158004

Taipei, , Taiwan

Site Status

Site TW158005

Taoyuan, , Taiwan

Site Status

Countries

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South Korea Taiwan

References

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Oh SJ, Cho ST, Kuo HC, Chou EC, Hsu YC, Lee KS, Hadi F, Song Y, Sumarsono B. Treatment Patterns with Mirabegron and Antimuscarinics for Overactive Bladder: A Prospective, Registry Study in Taiwan and South Korea (FAITH). Adv Ther. 2024 Apr;41(4):1652-1671. doi: 10.1007/s12325-024-02784-2. Epub 2024 Mar 2.

Reference Type DERIVED
PMID: 38430402 (View on PubMed)

Hadi F, Sumarsono B, Lee KS, Oh SJ, Cho ST, Hsu YC, Rasner P, Jenkins C, Fisher H. A treatment prediction strategy for overactive bladder using a machine learning algorithm that utilized data from the FAITH study. Neurourol Urodyn. 2023 Aug;42(6):1227-1237. doi: 10.1002/nau.25190. Epub 2023 May 6.

Reference Type DERIVED
PMID: 37148497 (View on PubMed)

Other Identifiers

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178-MA-3146

Identifier Type: -

Identifier Source: org_study_id

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