Overactive Bladder (OAB)NCT03572231
A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
An observational study of Overactive Bladder (OAB), run by Astellas Pharma Singapore Pte. Ltd. at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- mirabegron, solifenacin and darifenacin
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 805 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 19 Jul 2018to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and/or female adult OAB patients, whose physicians have decided to start OAB drug therapy in routine clinical practice.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
South Korea9 sites
Site KR410008
Daejeon
Site KR410009
Incheon
Site KR410005
Kangam
Site KR410001
Seoul
Site KR410002
Seoul
Site KR410003
Seoul
Site KR410006
Seoul
Site KR410007
Seoul
Site KR410004
Suwon
Taiwan6 sites
Site TW158001
Hualien City
Site TW158003
Kaohsiung City
Site TW158006
Kaohsiung City
Site TW158002
Taichung
Site TW158004
Taipei
Site TW158005
Taoyuan City
About this study
Official title: 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.
Read the 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.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- mirabegron, solifenacin, darifenacin, imidafenacin, tolterodine
- Keywords
- Betmiga, OAB, YM178, Overactive Bladder, mirabegron
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
Also called YM178, Betmiga
oral
solifenacinDevice
Also called YM905, Vesicare
oral
darifenacinDrug
oral
imidafenacinDrug
oral
tolterodineDrug
oral
oxybutyninDrug
oral
trospiumDrug
oral
fesoterodineDrug
oral
propiverineDevice
oral
| Study group | Role | What they receive |
|---|---|---|
| mirabegron | Participants will commence the OAB treatment with mirabegron that is prescribed by a physician in routine clinical practice. Receives: 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. Receives: Device: solifenacin; Drug: darifenacin; Drug: imidafenacin; Drug: tolterodine; Drug: oxybutynin; Drug: trospium; Drug: fesoterodine; Device: propiverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 26 weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start19 Jul 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Singapore Pte. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572231
- Sponsor's protocol ID
- 178-MA-3146
- Status last verified
- Apr 2020
- First submitted
- 19 Jun 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38430402Hadi 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.
PubMed 37148497
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China
- ClinicalTrials.gov ID
- NCT03572231
- Acronym / sponsor ID
- 178-MA-3146
- Conditions
- Overactive Bladder (OAB)
- Keywords
- Betmiga, OAB, YM178, Overactive Bladder, mirabegron
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mirabegron | – | Drug: mirabegronParticipants will commence the OAB treatment with mirabegron that is prescribed by a physician in routine clinical practice. |
| Antimuscarinics | – | Device: solifenacin, Drug: darifenacin, Drug: imidafenacin, Drug: tolterodine, Drug: oxybutynin, Drug: trospium, Drug: fesoterodine, Device: propiverineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and/or female adult OAB patients, whose physicians have decided to start OAB drug therapy in routine clinical practice.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirabegronAlso: YM178, Betmigaoral | Drug | mirabegron |
| solifenacinAlso: YM905, Vesicareoral | Device | Antimuscarinics |
| darifenacinoral | Drug | Antimuscarinics |
| imidafenacinoral | Drug | Antimuscarinics |
| tolterodineoral | Drug | Antimuscarinics |
| oxybutyninoral | Drug | Antimuscarinics |
| trospiumoral | Drug | Antimuscarinics |
| fesoterodineoral | Drug | Antimuscarinics |
| propiverineoral | Device | Antimuscarinics |
Primary outcome
Time from treatment initiation to discontinuation of Overactive Bladder (OAB) therapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
14 secondary outcomes
Change from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score
Time frame: Baseline, weeks 10-14 and weeks 22-26
Change from baseline in Bladder Assessment Tool (BAT) score
Time frame: Baseline, weeks 10-14 and weeks 22-26
Change from baseline in Overactive Bladder Symptom Scores (OABSS) score
Time frame: Baseline, weeks 10-14 and weeks 22-26
Change from baseline in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score
Time frame: 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
Time frame: Baseline (up to Day 0)
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: OAB Medical History
Time frame: 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
Time frame: Baseline (up to Day 0)
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Medical history
Time frame: Baseline (up to Day 0)
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medication information
Time frame: Up to 26 weeks
Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medical conditions
Time frame: Up to 26 weeks
Health Care Resource Utilization (HCRU) related to the management of OAB
Time frame: Up to 26 weeks
Safety assessed by Adverse Events (AEs)
Time frame: Up to 26 weeks
Safety assessed by Serious Adverse Events (SAEs)
Time frame: Up to 26 weeks
Safety assessed by Adverse Drug Reaction (ADR)
Time frame: Up to 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 38430402Oh 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.
- Derived from this study: PubMed 37148497Hadi 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.
Related trials for Overactive Bladder (OAB)
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma Singapore Pte. Ltd.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder (OAB), run by Astellas Pharma Singapore Pte. Ltd. at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from treatment initiation to discontinuation of Overactive Bladder (OAB) therapy (time frame: Up to 26 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572231, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.