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

Overactive Bladder (OAB) Clinical Trial

Official title:

A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572231
• Other study ID #: 178-MA-3146
• Status: Completed
• Start date: July 19, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Drug:
• mirabegron
oral

Device:
• solifenacin
oral

Drug:
• darifenacin
oral
• imidafenacin
oral
• tolterodine
oral
• oxybutynin
oral
• trospium
oral
• fesoterodine
oral

Device:
• propiverine
oral

Locations

Country	Name	City	State
Korea, Republic of	Site KR410008	Daejeon
Korea, Republic of	Site KR410009	Incheon
Korea, Republic of	Site KR410005	Kangam
Korea, Republic of	Site KR410001	Seoul
Korea, Republic of	Site KR410002	Seoul
Korea, Republic of	Site KR410003	Seoul
Korea, Republic of	Site KR410006	Seoul
Korea, Republic of	Site KR410007	Seoul
Korea, Republic of	Site KR410004	Suwon
Taiwan	Site TW158001	Hualien City
Taiwan	Site TW158006	Kaohsiung
Taiwan	Site TW158003	Kaohsiung City
Taiwan	Site TW158002	Taichung
Taiwan	Site TW158004	Taipei
Taiwan	Site TW158005	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Singapore Pte. Ltd.

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	Baseline, weeks 10-14 and weeks 22-26
Secondary	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.	Baseline, weeks 10-14 and weeks 22-26
Secondary	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.	Baseline, weeks 10-14 and weeks 22-26
Secondary	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.	Baseline, weeks 10-14 and weeks 22-26
Secondary	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.	Baseline (up to Day 0)
Secondary	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.	Baseline (up to Day 0)
Secondary	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.	Baseline (up to Day 0)
Secondary	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.	Baseline (up to Day 0)
Secondary	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.	Up to 26 weeks
Secondary	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.	Up to 26 weeks
Secondary	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.	Up to 26 weeks
Secondary	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.	Up to 26 weeks
Secondary	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.	Up to 26 weeks
Secondary	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.	Up to 26 weeks