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Completed

NCT Number: NCT00743613

Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

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.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

UMass, Fitchburg Family Medicine Center, Fitchburg, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sexual Health Inventory for Men (SHIM)

Behavioral

Five question test with maximum score of 25 points administered on the initial visit. Erectile dysfunction is indirectly related to the score.

Other names: SHIM, Sexual Health Inventory for Men

Ankle-Brachial Index (ABI)

Procedure

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

Other names: Multi Dopplex II 8-mHz

Primary outcomes

  1. Sexual Health Inventory for Men (SHIM)

    Time frame: initial visit

Secondary outcomes

  1. Ankle-Brachial Index (ABI)

    Time frame: Initial Visit

Sponsors and collaborators

Lead sponsor

Bruton Avenue Family Practice

Other

Collaborators

  • Pfizer

Registry information

Acronym: PREPARED

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 29, 2008
Registry last updated
Sep 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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