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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Bruton Avenue Family Practice
ClinicalTrials.gov Identifier:
NCT00743613
First received: August 28, 2008
Last updated: September 2, 2008
Last verified: September 2008

August 28, 2008
September 2, 2008
February 2005
February 2008   (final data collection date for primary outcome measure)
Sexual Health Inventory for Men (SHIM) [ Time Frame: initial visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00743613 on ClinicalTrials.gov Archive Site
Ankle-Brachial Index (ABI) [ Time Frame: Initial Visit ] [ Designated as safety issue: No ]
Same as current
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Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

Men 50 years old or older with either diabetes, hypertension, hyperlipidemia and/or a history of tobacco use.

  • Erectile Dysfunction
  • Peripheral Arterial Disease
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
May 2008
February 2008   (final data collection date for primary outcome measure)

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.
Male
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00743613
PREPARED 001
No
James Travers Edwards, Jr., MD Principal investigator, Bruton Avenue Family Practice
Bruton Avenue Family Practice
Pfizer
Principal Investigator: James T Edwards, Jr, MS, MD Bruton Avenue Family Practice
Bruton Avenue Family Practice
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP