Pudendal Assessment in Erectile Dysfunction (INDEED)

University of Pennsylvania

Status: Terminated

Conditions: Erectile Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT01262833

811936

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

Cases

Description:

Patients with erectile dysfunction by ILEF questionnaire

Controls

Description:

Patients without erectile dysfunction by ILEF questionnaire