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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00574184
Recruitment Status : Completed
First Posted : December 17, 2007
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date December 13, 2007
First Posted Date December 17, 2007
Last Update Posted Date October 31, 2017
Study Start Date August 2005
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2007)
Distal aortography with iliofemoral run-off will be performed to evaluate disease in the common and internal iliac arteries. [ Time Frame: During Procedural Cath ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 14, 2007)
  • Selective angiography of the internal pudendal artery (and accessory pudendal artery if present) will be performed bilaterally. [ Time Frame: 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)
Official Title Pelvic Angiography in Non-Responders to Phosphodiesterase-5 Inhibitors (PANPI)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Erectile Dysfunction
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 14, 2007)
10
Original Actual Enrollment Same as current
Actual Study Completion Date March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00574184
Other Study ID Numbers 200513528
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party University of California, Davis
Original Responsible Party Jason Rogers, MD, University of California, Davis Medical Center
Current Study Sponsor University of California, Davis
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Jason Rogers, MD University of California, Davis
PRS Account University of California, Davis
Verification Date March 2008