Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction - Full Text View

Sponsors and Collaborators:	Bruton Avenue Family Practice Pfizer
Information provided by:	Bruton Avenue Family Practice
ClinicalTrials.gov Identifier:	NCT00743613

Purpose

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

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

Further study details as provided by Bruton Avenue Family Practice:

Primary Outcome Measures:

Sexual Health Inventory for Men (SHIM) [ Time Frame: initial visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ankle-Brachial Index (ABI) [ Time Frame: Initial Visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	175
Study Start Date:	February 2005
Study Completion Date:	May 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743613

Locations

United States, Massachusetts
UMass, Fitchburg Family Medicine Center
Fitchburg, Massachusetts, United States, 01420
United States, Virginia
Bruton Avenue Family Practice
Newport News, Virginia, United States, 23601
Mercury West Family Practice
Hampton, Virginia, United States, 23666
Williamsburg Medical Arts-Family Medicine
Williamsburg, Virginia, United States, 23185
Hilton Family Practice
Newport News, Virginia, United States, 23601

Sponsors and Collaborators

Bruton Avenue Family Practice

Pfizer

Investigators

Principal Investigator:

James T Edwards, Jr, MS, MD

Bruton Avenue Family Practice

More Information

Publications of Results:

Grover SA, Lowensteyn I, Kaouache M, Marchand S, Coupal L, DeCarolis E, Zoccoli J, Defoy I. The prevalence of erectile dysfunction in the primary care setting: importance of risk factors for diabetes and vascular disease. Arch Intern Med. 2006 Jan 23;166(2):213-9.

Gazzaruso C, Giordanetti S, De Amici E, Bertone G, Falcone C, Geroldi D, Fratino P, Solerte SB, Garzaniti A. Relationship between erectile dysfunction and silent myocardial ischemia in apparently uncomplicated type 2 diabetic patients. Circulation. 2004 Jul 6;110(1):22-6. Epub 2004 Jun 21.

Lue TF. Erectile dysfunction. N Engl J Med. 2000 Jun 15;342(24):1802-13. Review. No abstract available.

Solomon H, Man JW, Jackson G. Erectile dysfunction and the cardiovascular patient: endothelial dysfunction is the common denominator. Heart. 2003 Mar;89(3):251-3. Review.

Jackson G. Endothelial function and dysfunction. Int J Clin Pract. 2004 May;58(5):431. No abstract available.

Deedwania PC. Endothelium: a new target for cardiovascular therapeutics. J Am Coll Cardiol. 2000 Jan;35(1):67-70. No abstract available.

Hurairah H, Ferro A. The role of the endothelium in the control of vascular function. Int J Clin Pract. 2004 Feb;58(2):173-83. Review. No abstract available.

Kloner RA. Erectile dysfunction in the cardiac patient. Curr Urol Rep. 2003 Dec;4(6):466-71. Review.

Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30.

Cappelleri JC, Rosen RC. The Sexual Health Inventory for Men (SHIM): a 5-year review of research and clinical experience. Int J Impot Res. 2005 Jul-Aug;17(4):307-19. Review.

Sutton-Tyrrell K, Rihal C, Sellers MA, Burek K, Trudel J, Roubin G, Brooks MM, Grogan M, Sopko G, Keller N, Jandová R. Long-term prognostic value of clinically evident noncoronary vascular disease in patients undergoing coronary revascularization in the Bypass Angioplasty Revascularization Investigation (BARI). Am J Cardiol. 1998 Feb 15;81(4):375-81.

Carman TL, Fernandez BB Jr. A primary care approach to the patient with claudication. Am Fam Physician. 2000 Feb 15;61(4):1027-32, 1034. Review.

Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24.

Champion H. Erectile Dysfunction and Cardiovascular Disease: Carrots, Sticks, and Better Men's Health. Adv Stud Med. 6(4):163-170, 2006

Fedele D, Bortolotti A, Coscelli C, Santeusanio F, Chatenoud L, Colli E, Lavezzari M, Landoni M, Parazzini F. Erectile dysfunction in type 1 and type 2 diabetics in Italy. On behalf of Gruppo Italiano Studio Deficit Erettile nei Diabetici. Int J Epidemiol. 2000 Jun;29(3):524-31.

Brunton S: Raising the Profile of Peripheral Arterial Disease. AANP 18th Annual National Conference, July 1, 2003, Anaheim, CA.

Responsible Party:	Bruton Avenue Family Practice ( James Travers Edwards, Jr., MD Principal investigator )
Study ID Numbers:	PREPARED 001
Study First Received:	August 28, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00743613
Health Authority:	United States: Institutional Review Board

Keywords provided by Bruton Avenue Family Practice:

Erectile Dysfunction
ED
Peripheral Arterial Disease

PAD
Ankle-Brachial Index
ABI

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Peripheral Vascular Diseases
Mental Disorders

Vascular Diseases
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Cardiovascular Diseases
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 16, 2009