NCT05572918尚未招募不适用
Translation of a Novel Overactive Bladder 'Fingerprint' Into a Breakthrough Non-invasive Diagnostic Test for Use in a Point of Care Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Assessment of accuracy of a diagnostic test for overactive bladder
研究概览
简要总结
In order to develop a test to diagnose overactive bladder from urine, it is essential that this test is at least as accurate as the tools that clinicians currently use. As such, this study will compare the performance of the device in development to the performance of existing methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •The participant is willing and able to give informed consent for participation in the study
- •The participant has been diagnosed with over-active bladder
- •Aged 18 years or above
- •Male or Female
排除标准
- •The participant is unwilling to give informed consent for participation in the study
- •The participant is unable to represent their own interests or is particularly susceptible to coercion (i.e. is deemed as vulnerable)
- •The participant has been diagnosed with neurologic disease (stroke, MS, Parkinson's disease, spinal cord injury); history of uterine, cervical, vaginal or urethral cancer; history of cyclophosphamide use or any type of chemical cystitis; history of benign or malignant bladder tumours; has had Botulinum injections, neuromodulation or augmentation cystoplasty
- •Aged 17 years or younger.
结局指标
主要结局
Assessment of accuracy of a diagnostic test for overactive bladder
时间窗: December 2022 - November 2023
A prototype lateral flow immunoassay dipstick to detect specific urinary biomarkers for OAB, based on specific urinary biomarkers and with a dynamic range and sensitivity required for accurate OAB diagnosis.
次要结局
未报告次要终点
研究者
John S. Young
Professor of Translational Healthcare
Teesside University
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