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History of Changes for Study: NCT00574184
Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI) (PANPI)
Latest version (submitted October 27, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 14, 2007 None (earliest Version on record)
2 March 25, 2008 Recruitment Status and Study Status
3 October 27, 2017 Sponsor/Collaborators, Study Status and Oversight
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Study NCT00574184
Submitted Date:  December 14, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: 200513528
Brief Title: Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI) (PANPI)
Official Title: Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2007
Overall Status: Active, not recruiting
Study Start: August 2005
Primary Completion:
Study Completion: December 2009 [Anticipated]
First Submitted: December 13, 2007
First Submitted that
Met QC Criteria:
December 14, 2007
First Posted: December 17, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 14, 2007
Last Update Posted: December 17, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of California, Davis
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Erectile Dysfunction
Keywords: ED
Erectile Dysfunction
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Cross-Sectional
Biospecimen Retention:
Biospecimen Description:
Enrollment: 10 [Actual]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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:
1. Selective angiography of the internal pudendal artery (and accessory pudendal artery if present) will be performed bilaterally.
[ Time Frame: During Procedural Cath ]

2. 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 ]

Open or close this module Eligibility
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).
Sampling Method: Non-Probability Sample
Minimum Age: 50 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Study Officials: Jason Rogers, MD
Principal Investigator
University of California, Davis
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: UC Davis Health System
Available IPD/Information:

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