Noninvasive Ultrasound Assessment of Detrusor Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 2,023
- 试验地点
- 1
- 主要终点
- Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure
研究概览
简要总结
The purpose of this study is to test a new ultrasound method called Quantitative Ultrasound Bladder Vibrometry to detect abnormal bladder function.
详细描述
The purpose of this study is to evaluate the effectiveness of quantitative ultrasound bladder vibrometry (QUBV) as a noninvasive tool for detrusor overactivity assessment and for benign prostatic hyperplasia (BPH) treatment selection. Participants in this study will have a QUBV ultrasound performed at the same time as a urodynamic study that had been ordered as part of their regular clinical care.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 scheduled to undergo UDS for their clinical care for one of the included diagnoses.
- •Aim2: Inclusions: Age >45 scheduled to undergo selective photovaporization of the prostate.
排除标准
- •Aim1:Obesity (BMI >35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as for uterine or colorectal cancer), prior bladder surgery (including prostate resection), and pregnant or breast-feeding women.
- •Aim2:Obesity (BMI >35kg/m2), known neurologic disease impacting bladder function (e.g. spinal cord injury, multiple sclerosis, Parkinson's, prior cerebrovascular accident), previous pelvic radiation therapy, previous radical pelvic surgery (such as colorectal cancer).
结局指标
主要结局
Accuracy of quantitative ultrasound vibrometry for measuring detrusor pressure
时间窗: time Frame: Up to study completion, an average of 1 year
Will be reported including 95% confidence intervals derived from the cross-validation procedure.
次要结局
- Accuracy of quantitative ultrasound vibrometry for selecting BPH patients for de-obstructive surgery(time Frame: Up to study completion, an average of 1 year)