Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

Conditions
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Erectile Dysfunction, Peripheral Arterial Disease

Intervention / Treatment
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* Behavioral: Sexual Health Inventory for Men (SHIM)
* Procedure: Ankle-Brachial Index (ABI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Sexual Health Inventory for Men (SHIM)|Five question test with maximum score of 25 points administered on the initial visit. Erectile dysfunction is indirectly related to the score.|
|Procedure: Ankle-Brachial Index (ABI)|Measure Ankle-Brachial Index with a hand held doppler and sphygmomanometer to determine the ABI.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Health Inventory for Men (SHIM) |  | initial visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle-Brachial Index (ABI) |  | Initial Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, ED, Peripheral Arterial Disease, PAD, Ankle-Brachial Index, ABI