Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT02245334
Status:
UNKNOWN
Last Update Posted:
2014-09-22
First Post:
2014-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011206', 'term': 'Povidone-Iodine'}], 'ancestors': [{'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1578}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-18', 'studyFirstSubmitDate': '2014-09-10', 'studyFirstSubmitQcDate': '2014-09-17', 'lastUpdatePostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with febrile infection', 'timeFrame': '1 week', 'description': 'consider fever over 38 degree celsius or admission due to fever'}], 'secondaryOutcomes': [{'measure': 'voiding questionnaire', 'timeFrame': '1-2 week', 'description': 'check International Prostate Symptom Score (IPSS)'}, {'measure': 'sexual function questionnaire', 'timeFrame': '1-2 week', 'description': 'International Index of Erectile Function-5 (IIEF-5)'}, {'measure': 'quality of life questionnaire', 'timeFrame': '1-2 week', 'description': 'European Organization for Research and Treatment fo Cancer (EORTC) Quality of life Questionnaire (QLQ)-C30 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection', 'Prostatic Diseases', 'Misadventure During Aspirating Needle Biopsy']}, 'descriptionModule': {'briefSummary': 'To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy', 'detailedDescription': 'the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* who undergo transrectal prostate biopsy\n\nExclusion Criteria:\n\n* patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy'}, 'identificationModule': {'nctId': 'NCT02245334', 'briefTitle': 'A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy', 'orgStudyIdInfo': {'id': 'B-1403/243-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Povidone-iodine', 'description': 'povidone iodine pill', 'interventionNames': ['Drug: Povidone-Iodine']}, {'type': 'NO_INTERVENTION', 'label': 'no intervention', 'description': 'no intervention'}], 'interventions': [{'name': 'Povidone-Iodine', 'type': 'DRUG', 'otherNames': ['Gynobetadine'], 'description': '1 pill per biopsy', 'armGroupLabels': ['Povidone-iodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam', 'state': 'Gyunggi-do', 'country': 'South Korea', 'contacts': [{'name': 'Sangchul Lee, MD, PhD', 'role': 'CONTACT', 'email': 'uromedi@naver.com', 'phone': '+82-31-787-7345'}, {'name': 'Sangchul Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Urology, Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'centralContacts': [{'name': 'Sangchul Lee', 'role': 'CONTACT', 'email': 'uromedi@naver.com', 'phone': '+82-31-787-7345'}], 'overallOfficials': [{'name': 'Sangchul Lee, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}