Pudendal Assessment in Erectile Dysfunction (INDEED)
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Purpose
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.
| Condition |
|---|
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Erectile Dysfunction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Cohort Study of the Functional Significance of Internal Pudendal Artery Stenoses in Patients With Erectile Dysfunction |
- Pudendal Assessment in Erectile Dysfunction [ Time Frame: Up to Five years ] [ Designated as safety issue: No ]The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfuncion
- Pudendal Assessment in Erectile Dysfunction [ Time Frame: up to five years ] [ Designated as safety issue: No ]Secondary analyses will include correlation between bilateral disease and erectile dysfunction, as well as the contribution of small vessel disease (distal to the internal pudendal artery). The severity of disease by IIEF questionnaire will also be compared to the severity of disease by angiography. We will continue through 5-year follow-up of patients with yearly IIEF questionnaires to determine if changes in erectile dysfunction can be predicted by baseline internal pudendal artery disease.
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Cases
Patients with erectile dysfunction by ILEF questionnaire
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Controls
Patients without erectile dysfunction by ILEF questionnaire
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
sexually active men, scheduled for cardiac catheterization or peripheral artery catheterization, who have at least one risk factor for ED
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) will be excluded.
- Patients requiring urgent catheterization (e.g. acute coronary syndrome or cardiogenic shock) will also be excluded.
- 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) will be excluded, 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 will also be excluded.
Contacts and Locations| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Howard Herrmann, M.D. | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01262833 History of Changes |
| Other Study ID Numbers: | 811936 |
| Study First Received: | November 12, 2010 |
| Last Updated: | January 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male |
Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013