Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT04932902
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-01
First Post:
2021-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ManAgement of pRiapiSm and Its Impact on Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011317', 'term': 'Priapism'}], 'ancestors': [{'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2021-06-13', 'studyFirstSubmitQcDate': '2021-06-13', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IIEF-5 at 3 months', 'timeFrame': '3 months', 'description': 'Sexual function as reported by patient or measured by questionnaire'}], 'secondaryOutcomes': [{'measure': 'IIEF-5 at 6 months', 'timeFrame': '6 months', 'description': 'Sexual function as reported by patient or measured by questionnaire'}, {'measure': 'Requirement for surgical management of priapism', 'timeFrame': 'Within 1 month', 'description': 'Requirement for surgical management of priapism'}, {'measure': "Adverse events including erectile dysfunction, penile curvature/Peyronie's disease", 'timeFrame': '6 months', 'description': 'Adverse events'}, {'measure': 'Resolution', 'timeFrame': '30 minutes', 'description': "Resolution of acute priapism within 30' after the onset of treatment (defined as no need for further non-surgical/surgical interventions to resolve priapism episode)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Priapism']}, 'descriptionModule': {'briefSummary': 'Priapism is a urological emergency that is defined as a prolonged penile erection lasting more than 4 h, remaining despite orgasm and in the absence of sexual stimulation. There are three sub-types of priapism: Ischaemic, non- ischaemic and stuttering. The most common (95% cases) of these is ischaemic priapism (IP), which represents a compartment syndrome of the corpus cavernosa with minimal or no arterial flow into the penis. It causes time-dependent smooth muscle damage that can result in significant morbidity (including, permanent erectile dysfunction (ED), penile shortening, penile curvature and loss of girth) with- out prompt intervention.\n\nUnlike ischemic priapism, non-ischemic priapism is not a urologic emergency, both the American Urological Association (AUA) and the European Association of Urology (EAU) recommend conservative, non-operative, management for the treatment of NIP. Spontaneous resolution has been documented to occur in 62% of patients \\[1\\].\n\nDespite the very high burden of priapism and its time-dependent adverse effect on erectile function, few studies have comprehensively defined the clinical epidemiology of this complication nor have any compared sexual dysfunction in men with SCD with that in those without it. Evidence-based treatment strategies for priapism are currently lacking, especially in terms of sexual function.\n\nHowever, despite the various publications in the literature, even today the published studies show considerable bias, in terms of sample size, evaluation of reproducible outcomes, use of internationally validated questionnaires, well-defined follow-up evaluation, as well as the evaluation of outcome after medical or surgical treatment. For this reason, the purpose of this international register is precisely to shed light on what may be the responses to medical surgical treatment in patients with priapism, but in particular to set up a rational data collection that has solid scientific bases.', 'detailedDescription': "Aims and objectives\n\nBased on the previous premises, the aim of our study is to evaluate the impact of the management of priapism from a sexual and clinical long-term outcomes point of view.\n\nSexual outcomes will be assessed by measured questionnaire (e.g. IIEF-15) at 3-6 months after priapism.\n\nClinical outcomes will be registered as rates of resolution of acute priapism within 30' after the onset of treatment (defined as no need for further non-surgical/surgical interventions to resolve priapism episode), corporal injury (fibrosis or necrosis), adverse events including erectile dysfunction, penile curvature/Peyronie's disease, requirement for surgical management of priapism.\n\nSample size calculation\n\nSince the study is designed as a prospective data collection through a registry, and since there are no comparative analyses between different groups, it is not possible to identify a priori sample size. However, considering that the largest case history on the field of priapism amounts to a total of 112 patients \\[3\\], we believe that collecting data from a total of 200 patients is sufficient in order to obtain scientifically reliable results with a high scientific profile."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with priapism: ischemic, non-ischemic or stuttered.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Priapism\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04932902', 'acronym': 'MARS', 'briefTitle': 'ManAgement of pRiapiSm and Its Impact on Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Policlinic Hospital "G. Rodolico"'}, 'officialTitle': 'ManAgement of pRiapiSm and Its Impact on Outcomes: an International Register', 'orgStudyIdInfo': {'id': '122/2021'}}, 'contactsLocationsModule': {'locations': [{'zip': '95123', 'city': 'Catania', 'state': 'CT', 'country': 'Italy', 'facility': 'Giorgio Ivan Russo', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'University of Florence', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'University of Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'University of Varese', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Serviço de Urologia, Centro Hospitalar Universitário São João, Porto, Portugal', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Giorgio Ivan Russo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, Urology Unit, Policlinic Hospital G. Rodolico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinic Hospital "G. Rodolico"', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Association of Urology Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Giorgio Ivan Russo', 'investigatorFullName': 'Giorgio Ivan Russo', 'investigatorAffiliation': 'Policlinic Hospital "G. Rodolico"'}}}}