Clinical trial NCT00743613: Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction
Official title: Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Peripheral Arterial Disease
Keywords: Erectile Dysfunction
ED
Peripheral Arterial Disease
PAD
Ankle-Brachial Index
ABI
Lead sponsor: Bruton Avenue Family Practice
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-08-29
Enrollment: 175
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men 50 years old or older with either diabetes, hypertension, hyperlipidemia and/or a history of tobacco use.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sexual Health Inventory for Men (SHIM)
timeFrame: initial visit
Secondary outcomes:
measure: Ankle-Brachial Index (ABI)
timeFrame: Initial Visit
Other outcomes:
Locations:
city: Fitchburg
country: United States
facility: UMass, Fitchburg Family Medicine Center
state: Massachusetts
city: Hampton
country: United States
facility: Mercury West Family Practice
state: Virginia
city: Newport News
country: United States
facility: Bruton Avenue Family Practice
state: Virginia
city: Newport News
country: United States
facility: Hilton Family Practice
state: Virginia
city: Williamsburg
country: United States
facility: Williamsburg Medical Arts-Family Medicine
state: Virginia
Study officials:
affiliation: Bruton Avenue Family Practice
name: James T Edwards, Jr, MS, MD
role: PRINCIPAL_INVESTIGATOR
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