Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-02 @ 12:09 AM
Study NCT ID:
NCT04399057
Status:
UNKNOWN
Last Update Posted:
2020-05-22
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D010409', 'term': 'Penile Diseases'}], '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 322}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-18', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shear Wave elastosonografy and Erectile tissues Stiffness.', 'timeFrame': '15 days', 'description': 'use of shear wave elastosonography for the diagnosis of erectile dysfunction by measuring the stiffness of the erectile tissue. the rigidity of the cavernous bodies is expressed in numerical values obtained in Kilopascals.'}, {'measure': 'Shear Wave Elastosonography and IIEF5 questionnaire', 'timeFrame': '15 days', 'description': 'comparison between the score in the International index of Erectile Function short form questionnaire (minimum value is 5 and maximum value is 25) and the stiffness values obtained by elastosonography with numerical absolute values obtained in kilopascals'}, {'measure': 'Shear Wave elastosonography and EHS questionnaire', 'timeFrame': '15 days', 'description': 'comparison between the score in the Erectile hardness Score questionnaire (minimum value is 0 an maximum value is 4) and the stiffness absolute values obtained by elastosonography with the numerical values obtained in kilopascals'}], 'secondaryOutcomes': [{'measure': 'cut-off value at elastosonography and erectile dysfunction', 'timeFrame': '15 days', 'description': 'The secondary objective aim of the our study is was to establish a cut-off value expressed in kilopascal to the elastosonographic Shear Wave Eelastosonography examination identifies the patient may develop erectile dysfunction due to cavernous tissue rigidity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['erectile dysfunction', 'elastosonography', 'penile diseases', 'International index of erectile function', 'erectile hardness score'], 'conditions': ['Erectile Dysfunction', 'Penile Diseases']}, 'descriptionModule': {'briefSummary': 'the study proposes the use of a new non-invasive ultrasound method for the diagnosis of erectile dysfunction. in particular, the shear Wave elastosonosgraphy of the corpora cavernosa will be used. this last method quantitatively measures the rigidity of the analyzed tissues.', 'detailedDescription': 'erectile function is a complex mechanism in which the elasticity of the tissues that make up the corpora cavernosa is fundamental. indeed, anatomopathological studies have shown that in patients with erectile dysfunction the elastic fibers are replaced by inextensible collagen. the aim of the study is the correlation between penile stiffness measured with this new non-invasive diagnostic method - elastosonography of the corpora cavernosa - and the correlation with validated questionnaires. the international Index of Erectile Function (IIEF5) short form and the erectile Hardness Score (EHS) will be used.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the population chosen is male, who goes to the clinics for andrological problems.', 'eligibilityCriteria': "Inclusion Criteria:\n\nmale who came attended our general andrology clinic between January 2019 to January 2020.\n\nExclusion Criteria:\n\n1. with: age \\>80 years or \\<18 years. , 2\n2. diabetes,\n3. spinal trauma,\n4. treatment with continuous PDE5i,\n5. ischemic heart disease for less than 6 months,\n6. pelvic surgery for within less than 1 year,\n7. hypotestosteronemia (\\<8 nmol/L),\n8. La Peyronie's disease.\n9. penile trauma."}, 'identificationModule': {'nctId': 'NCT04399057', 'briefTitle': 'Shear Wave Elastography New Ultrasound Approach for the Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'a New Approach: the Use of Shear Wave Elastosonography of the Corpora Cavernosa for the Diagnosis of Erectile Dysfunction.', 'orgStudyIdInfo': {'id': 'EDSWE1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'andrological patients', 'description': 'shear wave elastosonography of the corpora cavernosa was performed to all patients who went to our clinic for andrological problems. in addition, the International Index of Erectile Function short form (IIEF5) questionnaire and the Erectile Hardness Score (EHS) questionnaire were administered.', 'interventionNames': ['Diagnostic Test: shear Wave Elastosonography']}], 'interventions': [{'name': 'shear Wave Elastosonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'both the left cavernous body and the right cavernous body are ideally divided longitudinally into three sections: proximal, middle and distal. subsequently for each section of the corpora cavernosa the stiffness of the tissue is calculated by means of a specific Region Of Interest (ROI). the result is expressed in Kilopascals and in a color scale. when registering the stiffness the patient is asked to hold their breath.', 'armGroupLabels': ['andrological patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05100', 'city': 'Terni', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisabetta Costantini, Professor', 'role': 'CONTACT', 'email': 'elisabetta.costantini@unipg.it', 'phone': '3283620614'}, {'name': 'Ester Illiano, MD', 'role': 'CONTACT', 'email': 'ester.illiano@inwind.it', 'phone': '3283620614'}, {'name': 'Ester Illiano, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elisabetta Costantini, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francesco Trama, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Elisabetta Costantini', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief U.O.C. Chirurgia Urologica ad indirizzo andrologico ed Uroginecologico', 'investigatorFullName': 'Elisabetta Costantini', 'investigatorAffiliation': 'University Of Perugia'}}}}