Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2026-01-20 @ 10:18 AM
Study NCT ID:
NCT02241902
Status:
UNKNOWN
Last Update Posted:
2014-09-16
First Post:
2014-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Postoperative Pyuria on Treatment Outcomes After PVP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D011776', 'term': 'Pyuria'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-15', 'studyFirstSubmitDate': '2014-09-13', 'studyFirstSubmitQcDate': '2014-09-15', 'lastUpdatePostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the subtotal storage symptoms score of the International Prostate Symptom Score (IPSS)', 'timeFrame': '1-week, and 1-, 3- and 6-months after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia', 'Pyuria']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to identify serial changes in the incidence of postoperative pyuria after the Photoselective Vaporization of the Prostate (PVP), to determine whether the presence of postoperative pyuria could be correlated with surgical outcomes after surgery and to identify predicting factors that influence on persistent pyuria after the PVP.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'men who underwent photoselective vaporization (PVP) using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men who underwent photoselective vaporization (PVP) using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment\n* sterile urine on urinalysis and urine culture before surgery\n* absence of indwelling urethral catheter before surgery\n\nExclusion Criteria:\n\n* previous diagnosis of prostate carcinoma or bladder cancer\n* co-existence of urinary stone\n* any antibiotic treatment within 2-weeks before surgery'}, 'identificationModule': {'nctId': 'NCT02241902', 'briefTitle': 'Impact of Postoperative Pyuria on Treatment Outcomes After PVP', 'organization': {'class': 'OTHER', 'fullName': 'DongGuk University'}, 'officialTitle': 'Does Postoperative Pyuria Influence Treatment Outcomes After Photoselective Vaporization of the Prostate (PVP)?: A Short-term Serial Follow-up Study', 'orgStudyIdInfo': {'id': 'MCho1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No pyuria'}, {'label': 'Persistent pyuria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '410-773', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Min Chul Cho, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'cmc1206@empal.com', 'phone': '82-31-961-7456', 'phoneExt': '7456'}], 'facility': 'Dongguk University ilsan Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}], 'centralContacts': [{'name': 'Min Chul Cho, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'cmc1206@empal.com', 'phone': '82-31-961-7456', 'phoneExt': '7456'}], 'overallOfficials': [{'name': 'Min Chul Cho, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DongGuk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DongGuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Min Chul Cho', 'investigatorAffiliation': 'DongGuk University'}}}}