Pudendal Assessment in Erectile Dysfunction | NCT01262833

Studies
Pudendal Assessment in Erectile Dysfunction

NCT01262833

Sponsor

University of Pennsylvania

Status

Terminated

Last Update Posted

Mar 14, 2014Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Erectile Dysfunction

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

data suggesting pudendal artery stenosis rarely being cause of ED

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Nov 12, 2010

First Submission Date that Met QC Criteria

Dec 16, 2010

First Posted Date

Dec 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2014

Last Update Posted Date

Mar 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Patients with erectile dysfunction by ILEF questionnaire
Controls		Patients without erectile dysfunction by ILEF questionnaire

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Howard Herrmann, M.D.	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

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