Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

Completed

• Conditions: Erectile Dysfunction; Peripheral Arterial Disease

• Registration Number: NCT00743613
• Lead Sponsor: Bruton Avenue Family Practice

Brief Summary

Erectile dysfunction is a common complaint and is found frequently in men with hyperlipidemia, hypertension, diabetes and those who smoke. ED may also be an early warning of peripheral arterial disease. This study is designed to look for a relationship between the degree of ED and the presence of PAD when associated with co-morbid conditions.

Detailed Description

Erectile dysfunction (ED) is a common complaint in the primary care office. It is frequently found in men with hyperlipidemia, hypertension, or diabetes, and may also be an early warning of peripheral arterial disease. We looked for a relationship between the degree of ED and the presence of PAD as measured by the Ankle Brachial Index (ABI) associated with co-morbid conditions. Men over the age of 50 with hyperlipidemia, diabetes, hypertension, or tobacco use were asked to complete a Sexual Health Inventory for Men (SHIM). An ABI was measured using a hand held Doppler. 175 men from two urban and three suburban Family Practices in Tidewater Virginia participated. Outcome measures included SHIM scores, ABI, Systolic Blood Pressure, LDL, Hemoglobin A1C and tobacco use. Moderate or severe erectile dysfunction (SHIM \< 11.0) was identified in 44% of participants. More than 12.5% of men with severe ED (SHIM \< 7.0) had an ABI positive for PAD at 0.95 or less. The results were adjusted for the presence of hyperlipidemia, hypertension, diabetes and tobacco use. Men with hypertension did not demonstrate a significant increase in the frequency of PAD compared to diabetics or smokers. Neither race nor age was found to increase the prevalence of ED. The complaint of erectile dysfunction in men over age 50 should prompt a physician to consider peripheral arterial disease. A simple self-administered SHIM test should help identify men at risk for PAD and suggest further evaluation if the score is 7.0 or less.

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2008-02
• Study Completion: 2008-05
• Study First Submitted: 2008-08-28
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-02
• Last Update Posted: 2008-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 175

Inclusion Criteria

• Men 50 years old or older
• Must have a history of diabetes, hypertension, hyperlipidemia and/or a history of tobacco use

Exclusion Criteria

• Men younger than 50 years of age
• No co-morbid condition such as diabetes, hypertension, hyperlipidemia and/or tobacco use.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sexual Health Inventory for Men (SHIM)	initial visit

Secondary Outcome Measures

Name	Time	Method
Ankle-Brachial Index (ABI)	Initial Visit

Trial Locations

Locations (5)

UMass, Fitchburg Family Medicine Center; 🇺🇸 Fitchburg, Massachusetts, United States

Bruton Avenue Family Practice; 🇺🇸 Newport News, Virginia, United States

Mercury West Family Practice; 🇺🇸 Hampton, Virginia, United States

Williamsburg Medical Arts-Family Medicine; 🇺🇸 Williamsburg, Virginia, United States

Hilton Family Practice; 🇺🇸 Newport News, Virginia, United States