Erectile DysfunctionINDEEDNCT01262833
Pudendal Assessment in Erectile Dysfunction
An observational study of Erectile Dysfunction, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: sexually active men, scheduled for cardiac catheterization or peripheral artery catheterization, who have at least one risk factor for ED
Who may be able to join
- As above, men with one risk factor for ED such as age>55, diabetes, hyperlipidemia, smoking, hypertension, coronary disease or peripheral arterial disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with erectile dysfunction by ILEF questionnaire | |
| Controls | Patients without erectile dysfunction by ILEF questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pudendal Assessment in Erectile Dysfunction
The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfunction
Measured: Up to Five years
Secondary outcomes (1)
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.
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: data suggesting pudendal artery stenosis rarely being cause of ED
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Herrmann, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262833
- Sponsor's protocol ID
- 811936
- Acronym
- INDEED
- Status last verified
- Jan 2012
- First submitted
- 12 Nov 2010
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of the Functional Significance of Internal Pudendal Artery Stenoses in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01262833
- Acronym / sponsor ID
- INDEED / 811936
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: data suggesting pudendal artery stenosis rarely being cause of ED
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with erectile dysfunction by ILEF questionnaire |
| Controls | – | –Patients without erectile dysfunction by ILEF questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- sexually active men, scheduled for cardiac catheterization or peripheral artery catheterization, who have at least one risk factor for ED
Key inclusion criteria (1 listed)
- As above, men with one risk factor for ED such as age>55, diabetes, hyperlipidemia, smoking, hypertension, coronary disease or peripheral arterial disease
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pudendal Assessment in Erectile Dysfunction
Time frame: Up to Five years
The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfunction
1 secondary outcome
Pudendal Assessment in Erectile Dysfunction
Time frame: up to five years
Results and safety
The study was stopped early (reason given: data suggesting pudendal artery stenosis rarely being cause of ED). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Herrmann, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: data suggesting pudendal artery stenosis rarely being cause of ED). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pudendal Assessment in Erectile Dysfunction (time frame: Up to Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2014.