- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574184
Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI) (PANPI)
October 27, 2017 updated by: University of California, Davis
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
10
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Distal aortography with iliofemoral run-off will be performed to evaluate disease in the common and internal iliac arteries.
Time Frame: During Procedural Cath
|
During Procedural Cath
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Selective angiography of the internal pudendal artery (and accessory pudendal artery if present) will be performed bilaterally.
Time Frame: During Procedural Cath
|
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.
Time Frame: During Procedural Cath
|
During Procedural Cath
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
December 13, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Actual)
October 31, 2017
Last Update Submitted That Met QC Criteria
October 27, 2017
Last Verified
March 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200513528
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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