An observational study in Erectile Dysfunction, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-14.
Sponsored by University of Pennsylvania · Observational
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.
698 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.
This study's enrollment of 10 is below the median of 135 across 120 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
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sexually active men, scheduled for cardiac catheterization or peripheral artery catheterization, who have at least one risk factor for ED
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Exclusion Criteria:
Patients with erectile dysfunction by ILEF questionnaire
Patients without erectile dysfunction by ILEF questionnaire
Pudendal Assessment in Erectile Dysfunction
The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfunction
Time frame: Up to Five years
Pudendal Assessment in Erectile Dysfunction
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.
Time frame: up to five years
This study is terminated, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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