Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-02 @ 7:35 PM
Study NCT ID:
NCT00901056
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2009-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Shock Wave Therapy for the Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-23', 'studyFirstSubmitDate': '2009-05-12', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IIEF score', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Rigid Score (RS)', 'timeFrame': '3 months'}, {'measure': 'Quality of Erection Questionnaire (QEQ)', 'timeFrame': '3 months'}, {'measure': 'Self-Esteem And Relationship Questionnaire (SEAR)', 'timeFrame': '3 months'}, {'measure': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT)', 'timeFrame': '3 months'}, {'measure': 'Side Effects', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ED', 'Erectile Dysfunction', 'Erectile dysfunction treated with PDE-5 inhibitors'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.\n\nThe hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.', 'detailedDescription': 'Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ED of more than 6 months\n* At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days\n* Positive response to PDE-5 inhibitors\n* IIEF-5 domain score of 12-20 denoting mild to severe ED\n* Non-Neurological pathology\n* Stable heterosexual relationship for more than 3 months\n\nExclusion Criteria:\n\n* NPT - normal/flat\n* Prior prostatectomy surgery\n* Any cause of ED other than vascular related\n* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities\n* Clinically significant chronic hematological disease\n* Cardiovascular conditions that prevent sexual activity\n* History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.\n* Cancer within the past 5 years.\n* Anti-androgens, oral or injectable androgens\n* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories'}, 'identificationModule': {'nctId': 'NCT00901056', 'briefTitle': 'Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medispec'}, 'officialTitle': 'Feasibility Study to Investigate the Effect of Low Intensity Shockwaves on Patients With Erectile Dysfunction Resulted From Vascular Origin', 'orgStudyIdInfo': {'id': 'ED-ESWT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treated Group', 'description': 'This group will receive actual shockwave treatment', 'interventionNames': ['Device: Extracorporeal Shockwave Therapy']}], 'interventions': [{'name': 'Extracorporeal Shockwave Therapy', 'type': 'DEVICE', 'otherNames': ['Vascuspec'], 'description': 'Energy Density - 0.02 - 0.15 mJ/mm2', 'armGroupLabels': ['Treated Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Yoram Vardi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medispec', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Rambam Health Care Campus', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Yoram Vardi', 'oldOrganization': 'Rambam Medical Center'}}}}