Clinical trial NCT03572231: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder (OAB)
Keywords: Betmiga
OAB
YM178
Overactive Bladder
mirabegron
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2018-06-28
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Time from treatment initiation to discontinuation of Overactive Bladder (OAB) therapy
timeFrame: Up to 26 weeks
measure: Time from treatment initiation to switching to another OAB therapy or dose
timeFrame: Up to 26 weeks
measure: Proportion of participants who discontinue OAB treatment
timeFrame: Up to 26 weeks
measure: Proportion of participants who switch to another treatment or dose
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: Change from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score
timeFrame: Baseline, weeks 10-14 and weeks 22-26
measure: Change from baseline in Bladder Assessment Tool (BAT) score
timeFrame: Baseline, weeks 10-14 and weeks 22-26
measure: Change from baseline in Overactive Bladder Symptom Scores (OABSS) score
timeFrame: Baseline, weeks 10-14 and weeks 22-26
measure: Change from baseline in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score
timeFrame: Baseline, weeks 10-14 and weeks 22-26
measure: Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Demographic Information
timeFrame: Baseline (up to Day 0)
measure: Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: OAB Medical History
timeFrame: Baseline (up to Day 0)
measure: Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: History of prior drug treatment for OAB
timeFrame: Baseline (up to Day 0)
measure: Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Medical history
timeFrame: Baseline (up to Day 0)
measure: Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medication information
timeFrame: Up to 26 weeks
measure: Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medical conditions
timeFrame: Up to 26 weeks
measure: Health Care Resource Utilization (HCRU) related to the management of OAB
timeFrame: Up to 26 weeks
measure: Safety assessed by Adverse Events (AEs)
timeFrame: Up to 26 weeks
measure: Safety assessed by Serious Adverse Events (SAEs)
timeFrame: Up to 26 weeks
measure: Safety assessed by Adverse Drug Reaction (ADR)
timeFrame: Up to 26 weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Site KR410008
city: Incheon
country: Korea, Republic of
facility: Site KR410009
city: Kangam
country: Korea, Republic of
facility: Site KR410005
city: Seoul
country: Korea, Republic of
facility: Site KR410001
city: Seoul
country: Korea, Republic of
facility: Site KR410002
city: Seoul
country: Korea, Republic of
facility: Site KR410003
city: Seoul
country: Korea, Republic of
facility: Site KR410006
city: Seoul
country: Korea, Republic of
facility: Site KR410007
city: Suwon
country: Korea, Republic of
facility: Site KR410004
city: Hualien City
country: Taiwan
facility: Site TW158001
city: Kaohsiung City
country: Taiwan
facility: Site TW158003
city: Kaohsiung
country: Taiwan
facility: Site TW158006
city: Taichung
country: Taiwan
facility: Site TW158002
city: Taipei
country: Taiwan
facility: Site TW158004
city: Taoyuan City
country: Taiwan
facility: Site TW158005
Study officials:
affiliation: Astellas Pharma Singapore Pte. Ltd.
name: Central Contact
role: STUDY_DIRECTOR
References: