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Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)

Information source: University of California, Davis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erectile Dysfunction

Phase: N/A

Status: Completed

Sponsored by: University of California, Davis

Official(s) and/or principal investigator(s):
Jason Rogers, MD, Principal Investigator, Affiliation: University of California, Davis

Summary

The specific aim of this pilot study is to describe the angiographic prevalence and pattern of internal pudendal artery (and associated inflow vessel) atherosclerosis in patients with erectile dysfunction who are non-responsive to PDE-5 inhibitors (i. e., Viagra) who are referred for clinically-indicated cardiac catheterization.

Clinical Details

Official title: Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)

Study design: Observational Model: Cohort, Time Perspective: Cross-Sectional

Primary outcome: Distal aortography with iliofemoral run-off will be performed to evaluate disease in the common and internal iliac arteries.

Secondary outcome:

Selective angiography of the internal pudendal artery (and accessory pudendal artery if present) will be performed bilaterally.

Intra-arterial nitroglycerin (or papaverine or tolazoline if nitroglycerin is contraindicated) will be used to facilitate angiographic visualization of the internal pudendal and penile arteries.

Detailed description: The specific aim of this study is to determine if the deep penile arteries can be seen angiographically from the iliac arteries to delineate penile vasculature. Significant obstructive atherosclerotic disease of the deep penile arteries may be present in impotent males. The etiology of erectile dysfunction is multifactorial and may involve vascular disease, endocrine disorders, neurologic disease, prescription medications, psychological issues and/or trauma in any given patient. Vascular disease in patients with erectile dysfunction may be due to trauma, congenital anomalies, or atherosclerosis.

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male patients

- at least 50 years

- erectile dysfunction

- dissatisfaction with their use of a phosphodiesterase-5 inhibitor

- coronary artery disease (or at risk for coronary artery disease)

- undergoing diagnostic cardiac catheterization or patients with peripheral vascular

disease undergoing peripheral arteriography Exclusion Criteria:

- Patients who respond favorably to phosphodiesterase-5 inhibitors

- known non-vascular etiologies of their erectile dysfunction

- probable neurogenic erectile dysfunction due to radiation injury, surgery, or

transurethral resection of the prostate

- calculated GFR < 60 ml/min/1. 73 m2 will also be excluded

- disease that necessitates complex percutaneous intervention will be excluded per the

investigators discretion

Locations and Contacts

Additional Information

UC Davis Health System

Starting date: August 2005
Last updated: March 25, 2008

Page last updated: August 23, 2015

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