Pudendal Assessment in Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— INDEED  

Official title:

A Cohort Study of the Functional Significance of Internal Pudendal Artery Stenoses in Patients With Erectile Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01262833
• Other study ID #: 811936
• Status: Terminated
• Phase: N/A
• First received: November 12, 2010
• Last updated: March 13, 2014
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: January 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pudendal Assessment in Erectile Dysfunction	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.	up to five years	No