EndoPAT Device for Endothelial Dysfunction in ED

Not Applicable

Not yet recruiting

• Conditions: Erectile Dysfunction; Hypogonadism, Male; Endothelial Dysfunction
• Interventions: Drug: Daily low-dose PDE5 inhibitor therapy; Drug: Testosterone therapy as per clinical guidelines.

• Registration Number: NCT06720597
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Study Start: 2025-05
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• Males 18 years old and above
• Diagnosed with erectile dysfunction or hypogonadism

Exclusion Criteria

• Patients without the above criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)	Daily low-dose PDE5 inhibitor therapy	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.
Testosterone Therapy in Hypogonadal Men	Testosterone therapy as per clinical guidelines.	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UCI Urology | Men's Health Center; 🇺🇸 Newport Beach, California, United States