Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-02-01 @ 8:38 AM
Study NCT ID:
NCT02063061
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2014-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-energy Linear Extracorporal Shock Wave Therapy for 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-23', 'studyFirstSubmitDate': '2014-01-09', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) outcome', 'timeFrame': '18 weeks', 'description': 'Assesed after complition af clinical trial'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': '18 weeks', 'description': 'During treatment period all patients will be examined for advers events'}], 'primaryOutcomes': [{'measure': 'International Index of Erectile Function (IIEF) outcome increases by 5 points', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Erectile Hardness Scale (EHS) outcome is equal or higher than 3.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['extracorporeal shock wave therapy ESWT', 'erectile dysfunction'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '23554844', 'type': 'RESULT', 'citation': 'Gruenwald I, Appel B, Kitrey ND, Vardi Y. Shockwave treatment of erectile dysfunction. Ther Adv Urol. 2013 Apr;5(2):95-9. doi: 10.1177/1756287212470696.'}, {'pmid': '22008059', 'type': 'RESULT', 'citation': 'Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy--a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012 Jan;9(1):259-64. doi: 10.1111/j.1743-6109.2011.02498.x. Epub 2011 Oct 18.'}, {'pmid': '20451317', 'type': 'RESULT', 'citation': 'Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.'}], 'seeAlsoLinks': [{'url': 'http://komite.regionsyddanmark.dk/wm258128', 'label': 'regional ethical committee'}, {'url': 'http://www.sdu.dk/', 'label': 'University of Southern Denmark'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether extracorporeal shock wave therapy (ESWT) is an effective treatment for erectile dysfunction.', 'detailedDescription': 'Erectile dysfunction has a negative impact on quality of life and relationships. Thirty to sixty- five percent of men over 40 years of age have erection disorders. Current challenges of medical treatment are met with high costs and risks of side effects. Emerging new therapy with low-energy shock waves stimulate production of endothelial growth factor and nitrogen oxide which results in angiogenesis. It is our aim to assess efficaciousness of this method on potential to improve erectile dysfunction. We propose a prospective double-blind, randomised, cross-over, sham-controlled trial, to assess how effective shock waves therapy is for erectile dysfunction. Patients will receive one treatment per week for ten weeks. Subjects will be followed for up to one year after treatment. Standardized questionnaires will assess study endpoints for erectile dysfunction. We hypothesize that shock wave therapy could represent a low cost, low risk treatment for erectile dysfunction in men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Erectile dysfunction for at least 6 months\n* In relationships\n* Patient accept not to use any other therapy against erectile dysfunction\n\nExclusion Criteria:\n\n* Prostatectomy\n* Radiotherapy in pelvis\n* Hormonal therapy against prostate cancer\n* Anatomical penis disorder\n* Penile prosthesis\n* Treatment with anticoagulants (except acetylsalicylic acid 75 mg)\n* Psychiatric disorder\n* Hypogonadism\n* IIEF score higher than 25\n* Pregnant partner og delivered within last 12 months\n* Critical health disease\n* Neurological disorders'}, 'identificationModule': {'nctId': 'NCT02063061', 'acronym': 'ESWTvsED', 'briefTitle': 'Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Low-energy Linear Extracorporal Shock Wave Therapy for Erectile Dysfunction.', 'orgStudyIdInfo': {'id': 'CIV-13-07-011546'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham treatment', 'description': 'Subject will answer standardized questionnaires. Sham treatment arm will receive initially 5 sham series and after they answer standardized questionnaires they will receive 5 series of active treatment. Afterwards patients will answer standardized questionnaires again.', 'interventionNames': ['Device: Sham treatment', 'Device: ESWT treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ESWT treatment', 'description': 'Subject will answer standardized questionnaires. Subjects will receive 10 treatments with ESWT. Afterwards patients will answer standardized questionnaires again.', 'interventionNames': ['Device: ESWT treatment']}], 'interventions': [{'name': 'Sham treatment', 'type': 'DEVICE', 'otherNames': ['Sham'], 'description': 'Patients will receive simulated treatment, with the same ESWT unit as in other arm. Placebo gel-pad is design to prevent shockwaves emission. Looks identical as active gel-pad.', 'armGroupLabels': ['Sham treatment']}, {'name': 'ESWT treatment', 'type': 'DEVICE', 'otherNames': ['ESWT'], 'description': 'ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.', 'armGroupLabels': ['ESWT treatment', 'Sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6400', 'city': 'Sønderborg', 'state': 'Southern Denmark', 'country': 'Denmark', 'facility': 'Hospital of Southern Denmark', 'geoPoint': {'lat': 54.90896, 'lon': 9.78917}}], 'overallOfficials': [{'name': 'Palle Oshter, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grzegorz Fojecki', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'Region of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Grzegorz Fojecki', 'investigatorAffiliation': 'University of Southern Denmark'}}}}