Endothelial Dysfunction, Erectile Dysfunction, Hypogonadism, Male
Conditions
Keywords
EndoPAT, Erectile Dysfunction, Hypogonadism, Endothelial Dysfunction, ED, Testosterone
Brief summary
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
Detailed description
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. Impact of PDE5 Inhibitors on Endothelial Function: Phosphodiesterase type 5 (PDE5) inhibitors are a first-line treatment for ED, known to improve erectile function by enhancing blood flow. However, their direct impact on endothelial function over time remains underexplored, particularly in terms of long-term cardiovascular outcomes. Effects of Testosterone Therapy on Endothelial Health: The influence of testosterone therapy on endothelial function in hypogonadal men is not well understood. There is conflicting evidence on whether testosterone therapy confers cardiovascular benefits or risks, necessitating comprehensive studies to determine its effects.
Interventions
DRUGDaily low-dose PDE5 inhibitor therapy
Neither arm of the study includes a control group, and the two interventions will not be compared directly. The primary objective is to evaluate endothelial function using the EndoPAT device at baseline, 3 months, and 6 months following the intervention in each arm.
DRUGTestosterone therapy as per clinical guidelines.
Neither arm of the study includes a control group, and the two interventions will not be compared directly. The primary objective is to evaluate endothelial function using the EndoPAT device at baseline, 3 months, and 6 months following the intervention.
Sponsors
University of California, Irvine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Intervention model description
Study groups: 1. 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. 2. 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. 3. 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males 18 years old and above * Diagnosed with erectile dysfunction or hypogonadism
Exclusion criteria
* Patients without the above criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Function as Measured by Reactive Hyperemia Index (RHI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Health Markers | From baseline to 3 months and 6 months post-intervention. | Successful Outcome: Statistically significant improvements in blood pressure, lipid profile, and blood glucose levels from baseline to 3 and 6 months. Failure: No significant changes or worsening of cardiovascular health markers. |
| Sexual Function Scores | From baseline to 3 months and 6 months post-intervention. | Successful Outcome: Statistically significant improvement in IIEF scores from baseline to 3 and 6 months. Failure: No significant changes or deterioration in sexual function scores. |
| Adverse Events | From baseline to 3 months and 6 months post-intervention. | Successful Outcome: Minimal and non-severe adverse events reported. Failure: High frequency or severe adverse events necessitating discontinuation of the intervention. |
Countries
United States
Contacts
CONTACTMuhammed AM Hammad, MBBCh
CONTACTElia Abou Chawareb, MD
PRINCIPAL_INVESTIGATORFaysal A Yafi, MD
University of California, Irvine
Outcome results
None listed