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

Completed

• Conditions: Erectile Dysfunction

• Registration Number: NCT00574184
• Lead Sponsor: University of California, Davis

Brief 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.

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Status Verified: 2008-03
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distal aortography with iliofemoral run-off will be performed to evaluate disease in the common and internal iliac arteries.	During Procedural Cath

Secondary Outcome Measures

Name	Time	Method
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.	During Procedural Cath
Selective angiography of the internal pudendal artery (and accessory pudendal artery if present) will be performed bilaterally.	During Procedural Cath