NCT02031653已完成不适用
Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- The Positive/Negative Predictive Value of Penile cuff test
研究概览
简要总结
To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia.
- Penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level of accuracy without the morbidity and expense of invasive Pressure flow study.
- Penile cuff test may be particularly useful in the counseling of patients prior to benign prostatic hyperplasia operation. Patients diagnosed as obstructed following a penile cuff test can be reassured that surgery has a high chance of resulting in symptomatic benefit
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score >= 12)
- •Patients scheduled to have pressure flow study.
- •Able to give fully informed consent
排除标准
- •Patients with urologic malignancies such as prostate cancer and bladder cancer
- •Patients underwent urethral, prostate surgery
- •Patients with urethral stricture or bladder diverticulum or bladder neck contracture
- •seems not to be appropriate to this study by the decision of investigators because of any other reasons
结局指标
主要结局
The Positive/Negative Predictive Value of Penile cuff test
时间窗: 5 hours
The proportion comparison of Good responder between obstructed and unobstructed patients in penile cuff test
时间窗: up to 3 months
good responder: The reduction in the International Prostatic Symptom Scores of more than 50% from the initial scores 3 months after operation.
次要结局
- The correlation of intra-vesical Pressure between Pressure flow study and penile cuff test(5 hours)
- The categorical change of penile cuff test normogram after BPH operation(up to 3 months)
- The difference of Pain visual analogue scale score between two diagnostic tests(5 hours)
- The PSA level change after benign prostatic hyperplasia operation in obstructed and non-obstructed patients.(up to 3 months .)
- The changes of International Prostatic Symptom Scores after BPH operation.(up to 3 months)
研究者
KYU-SUNG LEE
professor
Samsung Medical Center
研究点 (1)
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