A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 805
- 试验地点
- 15
- 主要终点
- Time from treatment initiation to discontinuation of Overactive Bladder (OAB) therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
mirabegron
Participants will commence the OAB treatment with mirabegron that is prescribed by a physician in routine clinical practice.
干预措施: mirabegron (Drug)
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.
干预措施: solifenacin (Device)
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.
干预措施: darifenacin (Drug)
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.
干预措施: imidafenacin (Drug)
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.
干预措施: tolterodine (Drug)
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.
干预措施: oxybutynin (Drug)
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.
干预措施: trospium (Drug)
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.
干预措施: fesoterodine (Drug)
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.
干预措施: propiverine (Device)
结局指标
主要结局
Time from treatment initiation to discontinuation of Overactive Bladder (OAB) therapy
时间窗: 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 discontinue OAB treatment
时间窗: 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
时间窗: 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 switch to another treatment or dose
时间窗: 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.
次要结局
- Change from baseline in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score(Baseline, weeks 10-14 and weeks 22-26)
- Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Medical history(Baseline (up to Day 0))
- Safety assessed by Serious Adverse Events (SAEs)(Up to 26 weeks)
- Safety assessed by Adverse Drug Reaction (ADR)(Up to 26 weeks)
- Change from baseline in Bladder Assessment Tool (BAT) score(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(Baseline (up to Day 0))
- Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: OAB Medical History(Baseline (up to Day 0))
- Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medication information(Up to 26 weeks)
- Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: Concomitant medical conditions(Up to 26 weeks)
- Health Care Resource Utilization (HCRU) related to the management of OAB(Up to 26 weeks)
- Change from baseline in Overactive Bladder Symptom Scores (OABSS) score(Baseline, weeks 10-14 and weeks 22-26)
- Change from baseline in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score(Baseline, weeks 10-14 and weeks 22-26)
- Identify factors associated with the effectiveness and persistence of a pharmacologic therapy for an OAB participant: History of prior drug treatment for OAB(Baseline (up to Day 0))
- Safety assessed by Adverse Events (AEs)(Up to 26 weeks)