Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

Peripheral Arterial Disease Clinical Trial

— PREPARED  

Official title:

Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743613
• Other study ID #: PREPARED 001
• Status: Completed
• Phase: N/A
• First received: August 28, 2008
• Last updated: September 2, 2008
• Start date: February 2005
• Est. completion date: May 2008

Study information

• Verified date: September 2008
• Source: Bruton Avenue Family Practice
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: May 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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.

Procedure:
• Ankle-Brachial Index (ABI)
Measure Ankle-Brachial Index with a hand held doppler and sphygmomanometer to determine the ABI.

Locations

Country	Name	City	State
United States	UMass, Fitchburg Family Medicine Center	Fitchburg	Massachusetts
United States	Mercury West Family Practice	Hampton	Virginia
United States	Bruton Avenue Family Practice	Newport News	Virginia
United States	Hilton Family Practice	Newport News	Virginia
United States	Williamsburg Medical Arts-Family Medicine	Williamsburg	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Bruton Avenue Family Practice	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (17)

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

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. — View Citation

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. — View Citation

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

Deedwania PC. Endothelium: a new target for cardiovascular therapeutics. J Am Coll Cardiol. 2000 Jan;35(1):67-70. — View Citation

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 — View Citation

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 J — View Citation

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( — View Citation

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(1 — View Citation

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. — View Citation

Jackson G. Endothelial function and dysfunction. Int J Clin Pract. 2004 May;58(5):431. — View Citation

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

Lue TF. Erectile dysfunction. N Engl J Med. 2000 Jun 15;342(24):1802-13. Review. — View Citation

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. — View Citation

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. — View Citation

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 B — View Citation

Vinick A, Richardson D. Erectile Dysfunction in Diabetes. Diabetic Reviews 6:16-33, 1998.

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Health Inventory for Men (SHIM)		initial visit	No
Secondary	Ankle-Brachial Index (ABI)		Initial Visit	No