Pudendal Assessment in Erectile Dysfunction (INDEED)
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.
|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.
|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)|
Patients with erectile dysfunction by ILEF questionnaire
Patients without erectile dysfunction by ILEF questionnaire
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Howard Herrmann, M.D.||University of Pennsylvania|