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

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00574184
First received: December 13, 2007
Last updated: March 25, 2008
Last verified: March 2008

December 13, 2007
March 25, 2008
August 2005
Not Provided
Distal aortography with iliofemoral run-off will be performed to evaluate disease in the common and internal iliac arteries. [ Time Frame: During Procedural Cath ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574184 on ClinicalTrials.gov Archive Site
  • Selective angiography of the internal pudendal artery (and accessory pudendal artery if present) will be performed bilaterally. [ Time Frame: During Procedural Cath ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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).

Erectile Dysfunction
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2008
Not Provided

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
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00574184
200513528
Yes
Jason Rogers, MD, University of California, Davis Medical Center
University of California, Davis
Not Provided
Principal Investigator: Jason Rogers, MD University of California, Davis
University of California, Davis
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP