Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-29 @ 6:11 AM
Study NCT ID:
NCT01274156
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on 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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Index of Erectile function- Erectile Function Domain', 'timeFrame': 'At screening and 17 weeks later at last visit', 'description': 'An increase in score of 5points and above will be considered success.'}], 'secondaryOutcomes': [{'measure': 'Rigidity scale', 'timeFrame': 'At screening and 17 weeks later at last visit', 'description': 'A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success'}, {'measure': 'Flow Mediated Dilatation Technique', 'timeFrame': 'At screening and 17 weeks later at last visit', 'description': 'A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erectile dysfunction', 'Low Intensity Shock Wave'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.', 'detailedDescription': 'This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ED of more than 6 months\n* Rigidity score ≥ 3 under PDE5i therapy\n* SHIM ≤21 under PDE5i therapy\n* Non- hormonal, neurological or psychological pathology\n* Stable heterosexual relationship for more than 3 months\n\nExclusion Criteria:\n\n* Prior prostatectomy surgery\n* Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities\n* Clinically significant chronic hematological disease\n* Anti-androgens, oral or injectable androgens\n* Radiotherapy in pelvic region'}, 'identificationModule': {'nctId': 'NCT01274156', 'acronym': 'LI-ESWT', 'briefTitle': 'Double Blind Placebo Controlled Study on the Effect of Extracorporal Shock Wave Therapy on Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': "The Effect of Low Intensity Shock Wave Therapy on Erectile Dysfunction in Patients Responding to PDE5i's", 'orgStudyIdInfo': {'id': '3060 RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'shock wave treatment', 'interventionNames': ['Device: "MEDISPEC" treatment probe', 'Device: "MEDISPEC" Low intensity shock waves']}, {'type': 'SHAM_COMPARATOR', 'label': '"MEDISPEC" Sham', 'description': '"MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe', 'interventionNames': ['Device: "MEDISPEC" Sham Probe', 'Device: Sham']}], 'interventions': [{'name': '"MEDISPEC" treatment probe', 'type': 'DEVICE', 'otherNames': ['VASCUSPEC'], 'description': '300 shocks in 5 different anatomical locations of the penis.', 'armGroupLabels': ['shock wave treatment']}, {'name': '"MEDISPEC" Sham Probe', 'type': 'DEVICE', 'otherNames': ['VASCUSPEC'], 'description': 'Sham probe applied same as treatment probe without energy', 'armGroupLabels': ['"MEDISPEC" Sham']}, {'name': '"MEDISPEC" Low intensity shock waves', 'type': 'DEVICE', 'otherNames': ['VASCULOSPEC'], 'description': 'Treatment parameters will be as follows: Intensity: 0.09 mj/mm2 ,300 shocks per site, on 5 penile anatomical sites. Total number of shock waves: 1500/ session Frequency of 120/min', 'armGroupLabels': ['shock wave treatment']}, {'name': 'Sham', 'type': 'DEVICE', 'otherNames': ['Vasculospec'], 'description': 'Probe does not deliver energy but creates same noise and sensation of active probe', 'armGroupLabels': ['"MEDISPEC" Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'state': 'Israel', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medispec', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Prof Yoram Vardi', 'oldOrganization': 'Rambam Healthcare Campus'}}}}