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

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00574184

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

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

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

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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	10
Study Start Date:	August 2005
Study Completion Date:	March 2008

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

Ages Eligible for Study:	50 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574184

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Jason Rogers, MD

University of California, Davis

More Information

UC Davis Health System This link exits the ClinicalTrials.gov site

Responsible Party:	University of California, Davis Medical Center ( Jason Rogers, MD )
Study ID Numbers:	200513528
Study First Received:	December 13, 2007
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00574184
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

ED
Erectile Dysfunction

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 16, 2009