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Completed

NCT Number: NCT00574184

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: During Procedural Cath

Secondary outcomes

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

    Time frame: During Procedural Cath

  2. 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.

    Time frame: During Procedural Cath

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Acronym: PANPI

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 17, 2007
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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