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Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

NCT ID: NCT00743613

Last Updated: 2008-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Erectile Dysfunction Peripheral Arterial Disease

Keywords

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Erectile Dysfunction ED Peripheral Arterial Disease PAD Ankle-Brachial Index ABI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type BEHAVIORAL

Ankle-Brachial Index (ABI)

Measure Ankle-Brachial Index with a hand held doppler and sphygmomanometer to determine the ABI.

Intervention Type PROCEDURE

Other Intervention Names

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SHIM Sexual Health Inventory for Men Multi Dopplex II 8-mHz

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Bruton Avenue Family Practice

OTHER

Sponsor Role lead

Responsible Party

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Bruton Avenue Family Practice

Principal Investigators

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James T Edwards, Jr, MS, MD

Role: PRINCIPAL_INVESTIGATOR

Bruton Avenue Family Practice

Locations

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UMass, Fitchburg Family Medicine Center

Fitchburg, Massachusetts, United States

Site Status

Mercury West Family Practice

Hampton, Virginia, United States

Site Status

Bruton Avenue Family Practice

Newport News, Virginia, United States

Site Status

Hilton Family Practice

Newport News, Virginia, United States

Site Status

Williamsburg Medical Arts-Family Medicine

Williamsburg, Virginia, United States

Site Status

Countries

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United States

References

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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. doi: 10.1001/archinte.166.2.213.

Reference Type RESULT
PMID: 16432091 (View on PubMed)

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. doi: 10.1161/01.CIR.0000133278.81226.C9. Epub 2004 Jun 21.

Reference Type RESULT
PMID: 15210604 (View on PubMed)

Lue TF. Erectile dysfunction. N Engl J Med. 2000 Jun 15;342(24):1802-13. doi: 10.1056/NEJM200006153422407. No abstract available.

Reference Type RESULT
PMID: 10853004 (View on PubMed)

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. doi: 10.1136/heart.89.3.251.

Reference Type RESULT
PMID: 12591819 (View on PubMed)

Jackson G. Endothelial function and dysfunction. Int J Clin Pract. 2004 May;58(5):431. doi: 10.1111/j.1368-5031.2004.00255.x. No abstract available.

Reference Type RESULT
PMID: 15206495 (View on PubMed)

Deedwania PC. Endothelium: a new target for cardiovascular therapeutics. J Am Coll Cardiol. 2000 Jan;35(1):67-70. doi: 10.1016/s0735-1097(99)00536-7. No abstract available.

Reference Type RESULT
PMID: 10636261 (View on PubMed)

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. doi: 10.1111/j.1368-5031.2004.0103.x. No abstract available.

Reference Type RESULT
PMID: 15055866 (View on PubMed)

Kloner RA. Erectile dysfunction in the cardiac patient. Curr Urol Rep. 2003 Dec;4(6):466-71. doi: 10.1007/s11934-003-0028-9.

Reference Type RESULT
PMID: 14622500 (View on PubMed)

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. doi: 10.1016/s0090-4295(97)00238-0.

Reference Type RESULT
PMID: 9187685 (View on PubMed)

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. doi: 10.1038/sj.ijir.3901327.

Reference Type RESULT
PMID: 15875061 (View on PubMed)

Sutton-Tyrrell K, Rihal C, Sellers MA, Burek K, Trudel J, Roubin G, Brooks MM, Grogan M, Sopko G, Keller N, Jandova 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. doi: 10.1016/s0002-9149(97)00934-x.

Reference Type RESULT
PMID: 9485122 (View on PubMed)

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.

Reference Type RESULT
PMID: 10706155 (View on PubMed)

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. doi: 10.1001/jama.286.11.1317.

Reference Type RESULT
PMID: 11560536 (View on PubMed)

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

Reference Type RESULT

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 10869326 (View on PubMed)

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

Reference Type RESULT

Other Identifiers

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PREPARED 001

Identifier Type: -

Identifier Source: org_study_id