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Pudendal Assessment in Erectile Dysfunction (INDEED)

This study has been terminated.
(data suggesting pudendal artery stenosis rarely being cause of ED)
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01262833
First received: November 12, 2010
Last updated: March 13, 2014
Last verified: January 2012

November 12, 2010
March 13, 2014
September 2010
September 2013   (final data collection date for primary outcome measure)
Pudendal Assessment in Erectile Dysfunction [ Time Frame: Up to Five years ] [ Designated as safety issue: No ]
The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfunction
Pudendal Assessment in Erectile Dysfunction [ Time Frame: Up to Five years ] [ Designated as safety issue: No ]
The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfuncion
Complete list of historical versions of study NCT01262833 on ClinicalTrials.gov Archive Site
Pudendal Assessment in Erectile Dysfunction [ Time Frame: up to five years ] [ Designated as safety issue: No ]
Secondary analyses will include correlation between bilateral disease and erectile dysfunction, as well as the contribution of small vessel disease (distal to the internal pudendal artery). The severity of disease by IIEF questionnaire will also be compared to the severity of disease by angiography. We will continue through 5-year follow-up of patients with yearly IIEF questionnaires to determine if changes in erectile dysfunction can be predicted by baseline internal pudendal artery disease.
Same as current
Not Provided
Not Provided
 
Pudendal Assessment in Erectile Dysfunction
A Cohort Study of the Functional Significance of Internal Pudendal Artery Stenoses in Patients With Erectile Dysfunction

The study will address the role of internal pudendal artery disease in erectile dysfunction (ED), and whether it might eventually be amenable to intervention with stenting. There is currently a small trial investigating the potential benefit of stenting for erectile dysfunction, but the relationship between pelvic arterial stenoses and erectile dysfunction is not yet proven. The investigators intend to perform angiography on patients both with and without erectile dysfunction, to see whether internal pudendal artery disease is more common in the population with erectile dysfunction. In addition to angiography, stenoses will be examined using fractional flow reserve. The degree of internal pudendal artery disease will then be correlated with the degree of erectile dysfunction using a validated questionnaire, the International Index of Erectile Function (IIEF). Patients will then complete IIEF questionnaires for 5 years to assess the relationship between internal pudendal artery disease and progression of erectile dysfunction.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

sexually active men, scheduled for cardiac catheterization or peripheral artery catheterization, who have at least one risk factor for ED

Erectile Dysfunction
Not Provided
  • Cases
    Patients with erectile dysfunction by ILEF questionnaire
  • Controls
    Patients without erectile dysfunction by ILEF questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • As above, men with one risk factor for ED such as age>55, diabetes, hyperlipidemia, smoking, hypertension, coronary disease or peripheral arterial disease

Exclusion Criteria:

  • Patients with ED from a non-arterial cause, including hormonal, neurological, or trauma-related (as determined by past medical history routinely performed prior to catheterization)
  • Patients requiring urgent catheterization (e.g. acute coronary syndrome or cardiogenic shock)
  • Patients with a creatinine >1.5 mg/dL and those deemed at increased renal risk (such as from receiving >200 mL of dye during the primary procedure, post renal transplant or single kidney), as the additional contrast dye required for angiography would pose an undue risk of progressive kidney disease
  • Patients with other illnesses that reduce their life expectancy to less than one year
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01262833
811936
Yes
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Howard Herrmann, M.D. University of Pennsylvania
University of Pennsylvania
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP