Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

NCT00743613

Last updated date
Study Location
UMass, Fitchburg Family Medicine Center
Fitchburg, Massachusetts, 01420, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction, Peripheral Arterial Disease
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men 50 years old or older

- Must have a history of diabetes, hypertension, hyperlipidemia and/or a history of tobacco use

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Men younger than 50 years of age


- No co-morbid condition such as diabetes, hypertension, hyperlipidemia and/or tobacco
use.

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Erectile Dysfunction, Peripheral Arterial DiseasePredicting Peripheral Arterial Disease in Men With Erectile Dysfunction
NCT00743613
  1. Fitchburg, Massachusetts
  2. Hampton, Virginia
  3. Newport News, Virginia
  4. Newport News, Virginia
  5. Williamsburg, Virginia
Male
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction
Official Title Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Erectile Dysfunction
  • Peripheral Arterial Disease
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 28, 2008)
175
Original Actual Enrollment Same as current
Actual Study Completion Date May 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:Male
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00743613
Other Study ID Numbers PREPARED 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party James Travers Edwards, Jr., MD Principal investigator, Bruton Avenue Family Practice
Study Sponsor Bruton Avenue Family Practice
Collaborators Pfizer
Investigators
Principal Investigator:James T Edwards, Jr, MS, MDBruton Avenue Family Practice
PRS Account Bruton Avenue Family Practice
Verification Date September 2008