Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 11:05 AM
Study NCT ID:
NCT01262833
Status:
TERMINATED
Last Update Posted:
2014-03-14
First Post:
2010-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pudendal Assessment in Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'data suggesting pudendal artery stenosis rarely being cause of ED', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-13', 'studyFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2010-12-16', 'lastUpdatePostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pudendal Assessment in Erectile Dysfunction', 'timeFrame': 'Up to Five years', 'description': 'The primary exposure will be hemodynamically significant internal pudendal artery stenoses as a predictor of erectile dysfunction'}], 'secondaryOutcomes': [{'measure': 'Pudendal Assessment in Erectile Dysfunction', 'timeFrame': 'up to five years', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'sexually active men, scheduled for cardiac catheterization or peripheral artery catheterization, who have at least one risk factor for ED', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* As above, men with one risk factor for ED such as age\\>55, diabetes, hyperlipidemia, smoking, hypertension, coronary disease or peripheral arterial disease\n\nExclusion Criteria:\n\n* 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)\n* Patients requiring urgent catheterization (e.g. acute coronary syndrome or cardiogenic shock)\n* 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\n* Patients with other illnesses that reduce their life expectancy to less than one year'}, 'identificationModule': {'nctId': 'NCT01262833', 'acronym': 'INDEED', 'briefTitle': 'Pudendal Assessment in Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Cohort Study of the Functional Significance of Internal Pudendal Artery Stenoses in Patients With Erectile Dysfunction', 'orgStudyIdInfo': {'id': '811936'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients with erectile dysfunction by ILEF questionnaire'}, {'label': 'Controls', 'description': 'Patients without erectile dysfunction by ILEF questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Howard Herrmann, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}