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Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction (PREPARED)

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ClinicalTrials.gov Identifier: NCT00743613
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : September 3, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Erectile Dysfunction Peripheral Arterial Disease Behavioral: Sexual Health Inventory for Men (SHIM) Procedure: Ankle-Brachial Index (ABI)

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 Design

Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction
Study Start Date : February 2005
Primary Completion Date : February 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    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.
    Other Names:
    • SHIM
    • Sexual Health Inventory for Men
    Procedure: Ankle-Brachial Index (ABI)
    Measure Ankle-Brachial Index with a hand held doppler and sphygmomanometer to determine the ABI.
    Other Name: Multi Dopplex II 8-mHz

Outcome Measures

Primary Outcome Measures :
  1. Sexual Health Inventory for Men (SHIM) [ Time Frame: initial visit ]

Secondary Outcome Measures :
  1. Ankle-Brachial Index (ABI) [ Time Frame: Initial Visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743613


Locations
United States, Massachusetts
UMass, Fitchburg Family Medicine Center
Fitchburg, Massachusetts, United States, 01420
United States, Virginia
Mercury West Family Practice
Hampton, Virginia, United States, 23666
Bruton Avenue Family Practice
Newport News, Virginia, United States, 23601
Hilton Family Practice
Newport News, Virginia, United States, 23601
Williamsburg Medical Arts-Family Medicine
Williamsburg, Virginia, United States, 23185
Sponsors and Collaborators
Bruton Avenue Family Practice
Pfizer
Investigators
Principal Investigator: James T Edwards, Jr, MS, MD Bruton Avenue Family Practice
More Information

Publications:
Champion H. Erectile Dysfunction and Cardiovascular Disease: Carrots, Sticks, and Better Men's Health. Adv Stud Med. 6(4):163-170, 2006
Vinick A, Richardson D. Erectile Dysfunction in Diabetes. Diabetic Reviews 6:16-33, 1998.
Brunton S: Raising the Profile of Peripheral Arterial Disease. AANP 18th Annual National Conference, July 1, 2003, Anaheim, CA.

Responsible Party: James Travers Edwards, Jr., MD Principal investigator, Bruton Avenue Family Practice
ClinicalTrials.gov Identifier: NCT00743613     History of Changes
Other Study ID Numbers: PREPARED 001
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: September 3, 2008
Last Verified: September 2008

Keywords provided by Bruton Avenue Family Practice:
Erectile Dysfunction
ED
Peripheral Arterial Disease
PAD
Ankle-Brachial Index
ABI

Additional relevant MeSH terms:
Erectile Dysfunction
Peripheral Arterial Disease
Peripheral Vascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases