Pudendal Assessment in Erectile Dysfunction

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

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-09-30

Brief Summary

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The study will address the role of internal pudendal artery disease in erectile dysfunction (ED), and whether it might eventually be amenable to intervention with stenting. There is currently a small trial investigating the potential benefit of stenting for erectile dysfunction, but the relationship between pelvic arterial stenoses and erectile dysfunction is not yet proven. The investigators intend to perform angiography on patients both with and without erectile dysfunction, to see whether internal pudendal artery disease is more common in the population with erectile dysfunction. In addition to angiography, stenoses will be examined using fractional flow reserve. The degree of internal pudendal artery disease will then be correlated with the degree of erectile dysfunction using a validated questionnaire, the International Index of Erectile Function (IIEF). Patients will then complete IIEF questionnaires for 5 years to assess the relationship between internal pudendal artery disease and progression of erectile dysfunction.

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Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Patients with erectile dysfunction by ILEF questionnaire

No interventions assigned to this group

Controls

Patients without erectile dysfunction by ILEF questionnaire

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* As above, men with one risk factor for ED such as age\>55, diabetes, hyperlipidemia, smoking, hypertension, coronary disease or peripheral arterial disease

Exclusion Criteria

* Patients with ED from a non-arterial cause, including hormonal, neurological, or trauma-related (as determined by past medical history routinely performed prior to catheterization)
* Patients requiring urgent catheterization (e.g. acute coronary syndrome or cardiogenic shock)
* Patients with a creatinine \>1.5 mg/dL and those deemed at increased renal risk (such as from receiving \>200 mL of dye during the primary procedure, post renal transplant or single kidney), as the additional contrast dye required for angiography would pose an undue risk of progressive kidney disease
* Patients with other illnesses that reduce their life expectancy to less than one year

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No