Utilizing EndoPAT Device for Endothelial Dysfunction Assessment in Erectile Dysfunction and Hormonal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Endothelial Function as Measured by Reactive Hyperemia Index (RHI)
研究概览
简要总结
To assess endothelial dysfunction in young men (aged 30-50) with vasculogenic ED identified through penile Doppler ultrasound.
To evaluate changes in endothelial function using EndoPAT before and 3-6 months after daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy.
To investigate endothelial function alterations in hypogonadal patients before and 3-6 months after initiating testosterone (T) therapy
详细描述
Endothelial Dysfunction and Cardiovascular Health: Endothelial dysfunction is characterized by impaired endothelium-dependent vasodilation, which is a critical factor in the development and progression of cardiovascular diseases. The endothelium, the thin layer of cells lining blood vessels, plays a pivotal role in vascular health by regulating blood flow, coagulation, and immune function. When the endothelium is not functioning properly, it can lead to a range of cardiovascular conditions, including atherosclerosis, hypertension, and erectile dysfunction (ED).
Erectile Dysfunction and Endothelial Dysfunction: ED is often an early marker of endothelial dysfunction and cardiovascular diseases. Vasculogenic ED, in particular, is linked to poor endothelial health, where impaired blood flow to the penile tissue results in the inability to achieve or maintain an erection. This condition shares common risk factors with other cardiovascular diseases, such as diabetes, hypertension, and hyperlipidemia, highlighting the interconnected nature of endothelial health and ED.
Hormonal Therapy and Endothelial Function: Testosterone therapy (T therapy) is commonly used to treat hypogonadism in men, a condition characterized by low testosterone levels. Hypogonadism itself is associated with an increased risk of cardiovascular diseases, and testosterone therapy has been shown to have varying effects on endothelial function. While some studies suggest that testosterone may improve endothelial health, others indicate potential risks, necessitating further research to clarify its impact.
Current Gaps in Knowledge:
Prevalence of Endothelial Dysfunction in Young Men with ED: While the association between endothelial dysfunction and ED is established, there is a need for precise data on the prevalence and extent of endothelial dysfunction specifically in young men with vasculogenic ED. Understanding this prevalence can inform targeted treatment strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The data analysis will be conducted by statisticians blinded to the intervention status to reduce analysis bias. Data coding will be used to ensure that statisticians are unaware of the group assignments during the analysis phase.
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
- •Males 18 years old and above
- •Diagnosed with erectile dysfunction or hypogonadism
排除标准
- •Patients without the above criteria
研究组 & 干预措施
PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)
Population: 40 men aged 18 or above years diagnosed with vasculogenic ED. Intervention: Daily low-dose PDE5 inhibitor therapy. Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.
干预措施: Daily low-dose PDE5 inhibitor therapy (Drug)
Testosterone Therapy in Hypogonadal Men
Population: 40 hypogonadal men aged 18 or above Intervention: Testosterone therapy as per clinical guidelines. Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.
干预措施: Testosterone therapy as per clinical guidelines. (Drug)
Vasculogenic ED confirmed by penile Doppler ultrasound
Population: 40 men aged 18 or above years diagnosed with vasculogenic ED. Intervention: None Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.
结局指标
主要结局
Endothelial Function as Measured by Reactive Hyperemia Index (RHI)
时间窗: At baseline, 3 months, and 6 months post-intervention
Definition: RHI is a measure of endothelial function derived from the EndoPAT device, which assesses the endothelium's ability to respond to induced hyperemia. Measurement: RHI is calculated based on the changes in digital pulse volume during reactive hyperemia following a 5-minute arterial occlusion. Criteria for Evaluation: Baseline RHI: Measured before any intervention. Post-Intervention RHI: Measured at 3 months and 6 months post-intervention. Improvement in RHI: Defined as an increase in RHI scores from baseline to follow-up measurements.
次要结局
- Cardiovascular Health Markers(From baseline to 3 months and 6 months post-intervention.)
- Sexual Function Scores(From baseline to 3 months and 6 months post-intervention.)
- Adverse Events(From baseline to 3 months and 6 months post-intervention.)
研究者
Faysal Yafi
Associate Professor of Urology Director of Men's Health and Newport Urology Chief, Division of Men's Health and Reconstructive Urology
University of California, Irvine