Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-14 @ 2:27 PM
Study NCT ID:
NCT02573805
Status:
UNKNOWN
Last Update Posted:
2015-10-14
First Post:
2015-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D009127', 'term': 'Muscle Rigidity'}], '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'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Rigiscan parameters analyzed by Rigiscan plus software'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-10', 'studyFirstSubmitDate': '2015-10-09', 'studyFirstSubmitQcDate': '2015-10-09', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Previous Rigiscan parameters analyzed by Rigiscan plus software', 'timeFrame': 'within 2 days after the Rigiscan test', 'description': 'number of erectile events (per night), Duration of tip erections≥60% (min),duration of base erections ≥ 60% (min)'}], 'secondaryOutcomes': [{'measure': 'newly developed Rigiscan parameters analyzed by Rigiscan plus software', 'timeFrame': 'within 2 days after the Rigiscan test', 'description': 'RAU tip, TAU tip, RAU base, TAU base, average tip tumescence (cm), average base tumescence(cm), average event rigidity of tip (%),aveage event rigidity of base (%)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nocturnal penile tumescence and rigidity', 'erectile dysfunction', 'Chinese males'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the diagnostic value of Rigiscan (nocturnal penile tumescence and rigidity, NPTR ) test in erectile dysfunction of Chinese males.', 'detailedDescription': 'The Rigiscan test is used to evaluate the NPTR parameters. The "normal" NPTR parameter is provided by the Rigiscan manufacturer based on a clinical study on 500 American males. Original studies of NPTR parameters on Chinese males are warranted. On the other hand, during the past decades, several new NPTR parameters have been developed, like tip TAU (tip tumescence activity units), tip RAU (tip rigidity activity units), base TAU (base tumescence activity units), base RAU (base rigidity activity units), but their diagnostic values have been less evaluated. Basd on the these background, we determined to observe the clinical manifestation of these new parameters and to establish the "normal criteria" of NPTR parameters in Chinese males. This could be clinically beneficial in the differential diagnosis of organic and psychological erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese males ≥20 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients in a stable and heterosexual partnership with a fixed sexual partner for more than 6 months;\n2. age≥20 year;\n3. complete the validated International Index of Erectile Function (IIEF-5) questionnaire.\n\nExclusion Criteria:\n\n1. advanced age (≥65);\n2. pelvic trauma\n3. thyroid diseases\n4. metabolic diseases\n5. hypogonadism and other hormonal disorders\n6. sleep disorders\n7. penile deformities\n8. taking drugs that may interfere with erectile function.'}, 'identificationModule': {'nctId': 'NCT02573805', 'acronym': 'NPTR', 'briefTitle': 'the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'the Evaluation of Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males', 'orgStudyIdInfo': {'id': 'NPTR in 2015-09-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'erectile dysfunction group', 'description': 'International Index of Erectile Function (IIEF-5) questionnaire≥22 Rigiscan test are performed for two nights', 'interventionNames': ['Device: Rigiscan test']}, {'label': 'control group', 'description': 'International Index of Erectile Function (IIEF-5) questionnaire\\<22 Rigiscan test are performed for two nights', 'interventionNames': ['Device: Rigiscan test']}], 'interventions': [{'name': 'Rigiscan test', 'type': 'DEVICE', 'description': 'Rigiscan tests are performed in enrolled subjects for consecutive two nights.', 'armGroupLabels': ['control group', 'erectile dysfunction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Yutian Dai', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'l zhu, doctor', 'role': 'CONTACT', 'email': '13770864680@163.com', 'phone': '+8602568182222'}, {'name': 'yutian dai, doctor', 'role': 'CONTACT', 'email': '13913957628@163.com', 'phone': '+8602568182222'}], 'overallOfficials': [{'name': 'l zhu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drum tower Hospital, school of Medicine, Nanjing University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor leilei zhu', 'investigatorFullName': 'Leilei Zhu', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}