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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00574184
First Posted: December 17, 2007
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  Purpose
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.

Condition
Erectile Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Selective angiography of the internal pudendal artery (and accessory pudendal artery if present) will be performed bilaterally. [ Time Frame: During Procedural Cath ]
  • 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 ]

Enrollment: 10
Study Start Date: August 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will include males who are scheduled to undergo cardiac catheterization or peripheral arteriography at UC Davis Medical Center who have erectile dysfunction and poor response to oral phosphodiesterase-5 inhibitors (Viagra, Cialis and Levitra) as determined by their response to a standardized questionnaire. Dissatisfaction will be defined as a score of 21 or less on the ILEF-5 (International Index of Erectile Function questionnaire).
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574184


Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Jason Rogers, MD University of California, Davis
  More Information

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00574184     History of Changes
Other Study ID Numbers: 200513528
First Submitted: December 13, 2007
First Posted: December 17, 2007
Last Update Posted: October 31, 2017
Last Verified: March 2008

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
ED
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action