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Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00743613
Acronym
PREPARED
Enrollment
175
Registered
2008-08-29
Start date
2005-02-28
Completion date
2008-05-31
Last updated
2008-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Peripheral Arterial Disease

Keywords

Erectile Dysfunction, ED, Peripheral Arterial Disease, PAD, Ankle-Brachial Index, ABI

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.

Interventions

BEHAVIORALSexual 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.

Measure Ankle-Brachial Index with a hand held doppler and sphygmomanometer to determine the ABI.

Sponsors

Pfizer
CollaboratorINDUSTRY
Bruton Avenue Family Practice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Sexual Health Inventory for Men (SHIM)initial visit

Secondary

MeasureTime frame
Ankle-Brachial Index (ABI)Initial Visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026