Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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. )

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
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 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 : July 19, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Group/Cohort 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




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572231


Contacts
Layout table for location contacts
Contact: Astellas Pharma Singapore Pte Ltd. +81-3-3244-0512 astellas.registration@astellas.com

Locations
Layout table for location information
Korea, Republic of
Site KR410008 Recruiting
Daejeon, Korea, Republic of
Site KR410009 Recruiting
Incheon, Korea, Republic of
Site KR410005 Recruiting
Kangam, Korea, Republic of
Site KR410001 Recruiting
Seoul, Korea, Republic of
Site KR410002 Recruiting
Seoul, Korea, Republic of
Site KR410003 Recruiting
Seoul, Korea, Republic of
Site KR410006 Recruiting
Seoul, Korea, Republic of
Site KR410007 Recruiting
Seoul, Korea, Republic of
Site KR410004 Recruiting
Suwon, Korea, Republic of
Taiwan
Site TW158001 Recruiting
Hualien City, Taiwan
Site TW158003 Recruiting
Kaohsiung City, Taiwan
Site TW158006 Recruiting
Kaohsiung, Taiwan
Site TW158002 Recruiting
Taichung, Taiwan
Site TW158004 Recruiting
Taipei, Taiwan
Site TW158005 Recruiting
Taoyuan City, Taiwan
Sponsors and Collaborators
Astellas Pharma Singapore Pte. Ltd.
Investigators
Layout table for investigator information
Study Director: Central Contact Astellas Pharma Singapore Pte. Ltd.

Layout table for additonal information
Responsible Party: Astellas Pharma Singapore Pte. Ltd.
ClinicalTrials.gov Identifier: NCT03572231     History of Changes
Other Study ID Numbers: 178-MA-3146
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. ):
Betmiga
OAB
YM178
Overactive Bladder
mirabegron
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Mirabegron
Tolterodine Tartrate
Oxybutynin
Fesoterodine
Darifenacin
Trospium chloride
Propiverine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents