AzTrials
AzTrials

Erectile DysfunctionPREPAREDNCT00743613

Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

An observational study of Erectile Dysfunction and Peripheral Arterial Disease, run by Bruton Avenue Family Practice at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 50 years and older, men onlyHealthy volunteers can take part
What is being tested?
Sexual Health Inventory for Men (SHIM) and Ankle-Brachial Index (ABI)
How many people
175 participants
Where
5 sitesUnited States
Study dates
Feb 2005to May 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • Men 50 years old or older
  • Must have a history of diabetes, hypertension, hyperlipidemia and/or a history of tobacco use

Who cannot join

  • Men younger than 50 years of age
  • No co-morbid condition such as diabetes, hypertension, hyperlipidemia and/or tobacco use.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • UMass, Fitchburg Family Medicine Center

    Fitchburg, Massachusetts, 01420

  • Mercury West Family Practice

    Hampton, Virginia, 23666

  • Bruton Avenue Family Practice

    Newport News, Virginia, 23601

  • Hilton Family Practice

    Newport News, Virginia, 23601

  • Williamsburg Medical Arts-Family Medicine

    Williamsburg, Virginia, 23185

Other trials in United States

About this study

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.

Read the 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.

Being tested
Sexual Health Inventory for Men (SHIM), Ankle-Brachial Index (ABI)
Keywords
Erectile Dysfunction, ED, Peripheral Arterial Disease, PAD, Ankle-Brachial Index, ABI
Medical subject headings
Erectile Dysfunction, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sexual Health Inventory for Men (SHIM)Behavioural

    Also called SHIM, Sexual Health Inventory for Men

    Five question test with maximum score of 25 points administered on the initial visit. Erectile dysfunction is indirectly related to the score.

  • Ankle-Brachial Index (ABI)Procedure or surgery

    Also called Multi Dopplex II 8-mHz

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sexual Health Inventory for Men (SHIM)

    Measured: initial visit

Secondary outcomes (1)

  1. Ankle-Brachial Index (ABI)

    Measured: Initial Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2008 (estimated)
  2. Study startFeb 2005
  3. Primary completionFeb 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00743613
Sponsor's protocol ID
PREPARED 001
Acronym
PREPARED
Status last verified
Sep 2008
First submitted
28 Aug 2008
Last updated
3 Sep 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16432091

  • 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.

    PubMed 15210604

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

    PubMed 10853004

  • 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.

    PubMed 12591819

  • 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.

    PubMed 15206495

  • 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.

    PubMed 10636261

  • 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.

    PubMed 15055866

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

    PubMed 14622500

  • 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.

    PubMed 9187685

  • 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.

    PubMed 15875061

  • 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.

    PubMed 9485122

  • 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.

    PubMed 10706155

  • 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.

    PubMed 11560536

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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Erectile Dysfunction and Peripheral Arterial Disease, run by Bruton Avenue Family Practice at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sexual Health Inventory for Men (SHIM) (time frame: initial visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00743613, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in