Clinical trial NCT00574184: Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)
Official title: Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: ED
Erectile Dysfunction
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 10
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

Eligibility 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

Primary outcomes:
measure: Distal aortography with iliofemoral run-off will be performed to evaluate disease in the common and internal iliac arteries.
timeFrame: During Procedural Cath
Secondary outcomes:
measure: Selective angiography of the internal pudendal artery (and accessory pudendal artery if present) will be performed bilaterally.
timeFrame: During Procedural Cath
measure: 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.
timeFrame: During Procedural Cath
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Jason Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References: