Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT01108367
Status:
COMPLETED
Last Update Posted:
2011-05-10
First Post:
2010-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate (HoLEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2011-05-09', 'studyFirstSubmitDate': '2010-04-20', 'studyFirstSubmitQcDate': '2010-04-21', 'lastUpdatePostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia', 'Incontinence']}, 'referencesModule': {'references': [{'pmid': '21538499', 'type': 'RESULT', 'citation': 'Cho MC, Park JH, Jeong MS, Yi JS, Ku JH, Oh SJ, Kim SW, Paick JS. Predictor of de novo urinary incontinence following holmium laser enucleation of the prostate. Neurourol Urodyn. 2011 Sep;30(7):1343-9. doi: 10.1002/nau.21050. Epub 2011 Apr 28.'}]}, 'descriptionModule': {'briefSummary': "In men, urinary incontinence (UI) is relatively uncommon, and usually associated with some forms of prostate surgery. Thus, one of the risks of surgery for benign prostate hyperplasia (BPH) is postoperative UI. The guidelines of the American Urological Association for BPH treatment indicate that UI (2\\~5%) is relevant complications after transurethral prostatectomy (TURP). Rassweiler et al., based on a review of publications stated that early UI may occur in up to 30-40% of patients after TURP. Rigatti et al. reported that early postoperative urgency UI occurred in 38.6% (TURP) and 44% (holmium laser enucleation of the prostate; HoLEP) of surgically treated patients at 1-month after the surgery. Recently, the follow-up data for patients treated with HoLEP showed that transient stress UI developed in up to 44% after HoLEP. Although this alternative surgical treatment such as HoLEP can be performed safely with minimal complications, patients often face debilitating UI during the postoperative period before any improvement in micturition parameters occurs. Although this symptom ameliorates within a relatively short time, it usually cause significant stress and anxiety to the patient as far as their durations is concerned. In addition to its economic cost, UI is a distressing condition that has major impacts on a patient's quality of life. Social withdrawal, isolation, and depression occur in some patients.\n\nBecause this problem is usually temporary, there has been little attempt at addressing the issue. Therefore, there has been no research devoted specifically to transient de novo UI associated with HoLEP.\n\n1\\. The aim of the present study was following:\n\n1. to investigate the incidence of transient de novo UI after HoLEP for BPH\n2. determine the predictors of early postoperative transient de novo UI."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'men who underwent HoLEP for lower urinary tract symptoms (LUTS) with BPH refractory to alpha blocker medication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age older than 50 years\n* presence of moderate or severe LUTS (International Prostate Symptom Score \\[IPSS\\] greater than 8)or maximum flow rate of less than 10 mL/s\n\nExclusion Criteria:\n\n* previous prostate surgery\n* urethral stricture\n* prostate carcinoma\n* neurogenic bladder disease'}, 'identificationModule': {'nctId': 'NCT01108367', 'briefTitle': 'Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate (HoLEP)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Predictor of Transient Urinary Incontinence Following Holmium Laser Enucleation of the Prostate', 'orgStudyIdInfo': {'id': 'HoLEPUI'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Min Chul Cho, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Jae-Seung Paick, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae-Seung Paick/M.D.,Ph.D.', 'oldOrganization': 'Seoul National University Hospital'}}}}