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

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ClinicalTrials.gov Identifier: NCT03572231
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. )

Tracking Information
First Submitted Date June 19, 2018
First Posted Date June 28, 2018
Last Update Posted Date May 9, 2019
Actual Study Start Date July 19, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2018)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03572231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 19, 2018)
  • Change from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
Official Title A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Overactive Bladder (OAB)
Intervention
  • Drug: mirabegron
    oral
    Other Names:
    • YM178
    • Betmiga
  • 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
Study Groups/Cohorts
  • mirabegron
    Participants will commence the OAB treatment with mirabegron that is prescribed by a physician in routine clinical practice.
    Intervention: 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.
    Interventions:
    • Device: solifenacin
    • Drug: darifenacin
    • Drug: imidafenacin
    • Drug: tolterodine
    • Drug: oxybutynin
    • Drug: trospium
    • Drug: fesoterodine
    • Device: propiverine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 19, 2018)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Astellas Pharma Singapore Pte Ltd. +81-3-3244-0512 astellas.registration@astellas.com
Listed Location Countries Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03572231
Other Study ID Numbers 178-MA-3146
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. )
Study Sponsor Astellas Pharma Singapore Pte. Ltd.
Collaborators Not Provided
Investigators
Study Director: Central Contact Astellas Pharma Singapore Pte. Ltd.
PRS Account Astellas Pharma Inc
Verification Date May 2019