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

NCT00574184 | Completed DMC

• 1 other identifier: 200513528
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erectile Dysfunction

Keywords

ED; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  During Procedural Cath

Secondary Outcomes (2)

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

  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.

  During Procedural Cath

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Related Links

• UC Davis Health System

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Jason Rogers, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 31, 2017

Record last verified: 2008-03