A Cohort Study of the Functional Significance of Internal Pudendal Artery Stenoses in Patients With Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pudendal Assessment in Erectile Dysfunction
研究概览
简要总结
The study will address the role of internal pudendal artery disease in erectile dysfunction (ED), and whether it might eventually be amenable to intervention with stenting. There is currently a small trial investigating the potential benefit of stenting for erectile dysfunction, but the relationship between pelvic arterial stenoses and erectile dysfunction is not yet proven. The investigators intend to perform angiography on patients both with and without erectile dysfunction, to see whether internal pudendal artery disease is more common in the population with erectile dysfunction. In addition to angiography, stenoses will be examined using fractional flow reserve. The degree of internal pudendal artery disease will then be correlated with the degree of erectile dysfunction using a validated questionnaire, the International Index of Erectile Function (IIEF). Patients will then complete IIEF questionnaires for 5 years to assess the relationship between internal pudendal artery disease and progression of erectile dysfunction.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •As above, men with one risk factor for ED such as age>55, diabetes, hyperlipidemia, smoking, hypertension, coronary disease or peripheral arterial disease
排除标准
- •Patients with ED from a non-arterial cause, including hormonal, neurological, or trauma-related (as determined by past medical history routinely performed prior to catheterization)
- •Patients requiring urgent catheterization (e.g. acute coronary syndrome or cardiogenic shock)
- •Patients with a creatinine >1.5 mg/dL and those deemed at increased renal risk (such as from receiving >200 mL of dye during the primary procedure, post renal transplant or single kidney), as the additional contrast dye required for angiography would pose an undue risk of progressive kidney disease
- •Patients with other illnesses that reduce their life expectancy to less than one year
结局指标
主要结局
Pudendal Assessment in Erectile Dysfunction
时间窗: Up to Five years
The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfunction
次要结局
- Pudendal Assessment in Erectile Dysfunction(up to five years)