Pudendal Assessment in Erectile Dysfunction

NCT01262833 | Terminated DMC

• 1 other identifier: 811936
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Pudendal Assessment in Erectile Dysfunction

  The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfunction

  Up to Five years

Secondary Outcomes (1)

• Pudendal Assessment in Erectile Dysfunction

  up to five years

Study Arms (2)

Cases

Patients with erectile dysfunction by ILEF questionnaire

Controls

Patients without erectile dysfunction by ILEF questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

• Howard Herrmann, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: December 17, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 14, 2014

Record last verified: 2012-01

Locations

US (1)