Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-30 @ 6:37 PM
Study NCT ID:
NCT01262157
Status:
UNKNOWN
Last Update Posted:
2011-05-19
First Post:
2010-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2010-07-11', 'studyFirstSubmitQcDate': '2010-12-15', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IIEF-ED Domain', 'timeFrame': '17 weeks', 'description': 'A change of 5 points or more will indicate success'}], 'secondaryOutcomes': [{'measure': 'rigidity score', 'timeFrame': '17 weeks', 'description': 'a scale of 3 and above indicates success'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Erectile dysfunction', 'PDE5 Inhibitor', 'Low intensity shock wave therapy.'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).', 'detailedDescription': 'In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ED of more than 6 months\n* Rigidity score \\< 3 during PDE5i therapy\n* SHIM \\<21 during PDE5i therapy\n* Non- hormonal, neurological or psychological pathology 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': 'NCT01262157', 'acronym': 'LI-ESWT', 'briefTitle': 'Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy', 'orgStudyIdInfo': {'id': '507-10 RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'placebo', 'description': 'We use the same probe that induces the same sensation on the penis and the same noise yet no energy', 'interventionNames': ['Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shock wave therapy', 'description': '12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment', 'interventionNames': ['Device: Low intensity shock wave therapy']}], 'interventions': [{'name': 'Extracorporeal Shockwave Therapy Generator (Vascuspec)', 'type': 'DEVICE', 'otherNames': ['Low intensity shock wave Therapy', 'Extracorporeal Shockwave Therapy'], 'description': 'Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.', 'armGroupLabels': ['placebo']}, {'name': 'Low intensity shock wave therapy', 'type': 'DEVICE', 'otherNames': ['Low Intensity Extra Corporal Shock Wave Therapy'], 'description': 'Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.', 'armGroupLabels': ['Shock wave therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'state': 'Israel', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yoram Vardi, Prof', 'role': 'CONTACT', 'email': 'yvardi@rambam.health.gov.il', 'phone': '++97248542819'}, {'name': 'Ilan Gruenwald, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Boaz Appel, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Yoram Vardi, Prof', 'role': 'CONTACT', 'email': 'yvardi@rambam.health.gov.il', 'phone': '++97248542819'}, {'name': 'Ilan Gruenwald, MD', 'role': 'CONTACT', 'email': 'i_gruenwald@rambam.health.gov.il', 'phone': '++97248542819'}], 'overallOfficials': [{'name': 'Yoram Vardi, prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Yoram Vardi', 'oldOrganization': 'Rambam Health Care Campus'}}}}