Continence Care Registry (ConCaRe™)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Creation of longitudinal continence care ePRO-based, direct-to-consumer registry
研究概览
简要总结
This observational research study aims to build a multinational electronic patient-reported outcomes (ePRO) registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and other various aspects of using an intermittent catheter.
详细描述
This observational research study aims to build a multinational ePRO registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra to manage urinary retention and incomplete bladder emptying. Research resulting from data generated from an ePRO registry will factor in end user perspectives on intermittent catheterization habits and behaviors and intermittent catheter performance to inform and guide healthcare providers, end users, and caregivers in making the most informed healthcare decisions regarding intermittent catheterization. Research participants will be asked to self-report on various attributes of their currently prescribed intermittent catheters and various aspects of habits and behaviors, including health-related quality of life, of using an intermittent catheter.
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
- •Is at least 18 years of age; male or female.
- •Is performing transurethral intermittent catheterization.
- •Uses intermittent catheter(s) from any manufacturer as a form of management for urinary retention or incomplete bladder emptying.
- •Must be able to provide informed consent and have no cognitive impairment that would hinder the ability to provide informed consent or self-reported data.
- •Lives and has permanent residence in one of the countries that the study is being conducted at time of enrollment (USA, Canada, UK, Germany, France, The Netherlands, or Italy)
- •Is willing and able to complete electronic questionnaires monthly for the first year of data collection and quarterly thereafter or appoint a caregiver proxy.
- •Is able to read and respond to the questionnaires in the language options provided for a given country (e.g. French Canadian or English for Canada)
排除标准
- •Performs non transurethral catheterization, e.g., stoma.
- •Participating in a clinical study involving transurethral intermittent self-catheterization at the time of enrollment.
- •Employee of Sponsor at the time of enrollment.
结局指标
主要结局
Creation of longitudinal continence care ePRO-based, direct-to-consumer registry
时间窗: 5 years
To build a longitudinal continence care ePRO-based, direct-to-consumer registry addressing overall intermittent self-catheterization product satisfaction, QoL, healthcare resource utilization associated with urinary symptoms, urinary tract infections and other complications including burden of ISC over time, and end-user product preference factors.
次要结局
- Identification of intermittent self-catheterization habits and behaviors(5 years)