Composur, a Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 63
- 主要终点
- Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q)
研究概览
简要总结
This study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with Vibegron for the treatment of OAB in the context of real-world clinical practice.
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
- •Diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
- •Symptoms of OAB for at least 3 months prior to the Baseline Visit
- •Willing and able to complete electronic patient-reported outcomes questionnaires monthly for a minimum of 1 year
- •Previous exposure to anticholinergics or mirabegron monotherapy and/or mirabegron plus solifenacin combination therapy prior to initiation of vibegron
排除标准
- •Any contraindication to the use of vibegron per the United States label
- •History of OAB treatment with botulinum toxin A; sacral neuromodulation; percutaneous tibial nerve stimulation; external beam radiation therapy; urinary stents within the last 6 months; pelvic or lower urinary tract surgery within the last 6 months; and urethral catheterizations within the last 3 months prior to the Baseline Visit
- •History of mixed incontinence where stress incontinence is the predominant form (as determined by the investigator)
- •Participants at risk of urinary retention (as determined by the investigator)
- •Neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
- •Pregnant or breastfeeding or plans to do so during the study
- •Use of vibegron prior to the Baseline Visit either prescribed or in a previous vibegron clinical trial where the participant was on vibegron
- •Anyone who, at the discretion of the investigator, is not suitable for treatment with a beta 3 agonist for OAB for any reason
研究组 & 干预措施
Cohort A Vibegron
Participants with previous anticholinergic therapy experience will receive vibegron as per the United States (U.S.) label.
干预措施: Vibegron (Drug)
Cohort B Vibegron
Participants with previous mirabegron monotherapy or mirabegron plus solifenacin or combination therapy experience will receive vibegron as per the U.S. label.
干预措施: Vibegron (Drug)
结局指标
主要结局
Mean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q)
时间窗: Month 3
The OAB-SAT-q is an 11-item questionnaire designed to assess participant's satisfaction with overactive bladder treatment in the clinical setting. It includes 3 subscales (satisfaction, side effects, endorsement) and 2 single-item assessments (convenience, preference), with a 4-week recall period. The OAB-SAT-q is scored by domains ranging from 0-100. Scores for the Convenience item range from 0-100. The Preference item is calculated as a percentage. Higher scores indicate higher levels of treatment satisfaction, endorsement, and convenience.
Mean Satisfaction Domain Score as Assessed by the OAB-SAT-q
时间窗: Month 12
The OAB-SAT-q is an 11-item questionnaire designed to assess participant's satisfaction with overactive bladder treatment in the clinical setting. It includes 3 subscales (satisfaction, side effects, endorsement) and 2 single-item assessments (convenience, preference), with a 4-week recall period. The OAB-SAT-q is scored by domains ranging from 0-100. Scores for the Convenience item range from 0-100. The Preference item is calculated as a percentage. Higher scores indicate higher levels of treatment satisfaction, endorsement, and convenience.
次要结局
- Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q(Month 3, Month 6 and Month 12)
- Mean Duration of Vibegron Treatment(Month 3, Month 6 and Month 12)
- Number of Participants Discontinuing Vibegron Treatment for the Indicated Reasons(Month 3, Month 6 and Month 12)
- Mean Scores on the Side Effects, Endorsement, Convenience, and Preference Domains as Assessed by the OAB-SAT-q(Month 3, Month 6 and Month 12)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Up to Month 12)
- Percentage of Participants Discontinuing Vibegron Treatment for the Indicated Reasons(Month 3, Month 6 and Month 12)