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

NCT03572231 | Completed

• 1 other identifier: 178-MA-3146
• Study Type: observational
• Target: 805
• Locations: 2 countries
• Sites: 15

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.

Conditions

Overactive Bladder (OAB)

Keywords

Betmiga; OAB; YM178; Overactive Bladder; mirabegron

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Change from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score

  Baseline, weeks 10-14 and weeks 22-26

• Change from baseline in Bladder Assessment Tool (BAT) score

  Baseline, weeks 10-14 and weeks 22-26

• Change from baseline in Overactive Bladder Symptom Scores (OABSS) score

  Baseline, weeks 10-14 and weeks 22-26

• Change from baseline in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score

  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

  Baseline (up to Day 0)

Study Arms (2)

mirabegron

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

Drug: mirabegron

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; Drug: darifenacin; Drug: imidafenacin; Drug: tolterodine; Drug: oxybutynin; Drug: trospium; Drug: fesoterodine; Device: propiverine

Interventions

mirabegron DRUG

oral

Also known as: YM178, Betmiga

mirabegron

solifenacin DEVICE

oral

Also known as: YM905, Vesicare

Antimuscarinics

darifenacin DRUG

oral

Antimuscarinics

imidafenacin DRUG

oral

Antimuscarinics

tolterodine DRUG

oral

Antimuscarinics

oxybutynin DRUG

oral

Antimuscarinics

trospium DRUG

oral

Antimuscarinics

fesoterodine DRUG

oral

Antimuscarinics

propiverine DEVICE

oral

Antimuscarinics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Singapore Pte. Ltd.: lead

Study Sites (15)

Site KR410008

Daejeon, South Korea

Location

Site KR410009

Incheon, South Korea

Location

Site KR410005

Kangam, South Korea

Location

Site KR410001

Seoul, South Korea

Location

Site KR410002

Seoul, South Korea

Location

Site KR410003

Seoul, South Korea

Location

Site KR410006

Seoul, South Korea

Location

Site KR410007

Seoul, South Korea

Location

Site KR410004

Suwon, South Korea

Location

Site TW158001

Hualien City, Taiwan

Location

Site TW158003

Kaohsiung City, Taiwan

Location

Site TW158006

Kaohsiung City, Taiwan

Location

Site TW158002

Taichung, Taiwan

Location

Site TW158004

Taipei, Taiwan

Location

Site TW158005

Taoyuan, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 38430402 DERIVED

• 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.

  PMID: 37148497 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron; darifenacin; imidafenacin; Tolterodine Tartrate; oxybutynin; trospium chloride; fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Central Contact

  Astellas Pharma Singapore Pte. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: July 19, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

KR (9); TW (6)