Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT06697106
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2024-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}], 'ancestors': [{'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2024-11-17', 'studyFirstSubmitQcDate': '2024-11-17', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urethral stricture recurrence', 'timeFrame': '90 days postoperative', 'description': 'Urethral stricture recurrence is defined as the need for a secondary procedure, including dilation, internal urethrotomy, and urethroplasty, considered as treatment failure.'}], 'secondaryOutcomes': [{'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': '90 days postoperative', 'description': 'The International Prostate Symptom Score (IPSS) will be used to assess lower urinary tract symptoms (LUTS). The IPSS consists of seven questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms.'}, {'measure': 'Quality of life (QOL)', 'timeFrame': '90 days postoperative', 'description': 'Quality of life (QOL) will be used to assess lower urinary tract symptoms (LUTS). Patients will answer using a Likert scale, with four or five response options per item, and scores range from 0 (best QoL) to 13 (worst QoL).'}, {'measure': 'Maximum flow rate', 'timeFrame': '90 days postoperative', 'description': 'Maximum flow rate (Q.max) will be used to assess lower urinary tract symptoms (LUTS).'}, {'measure': 'Incidence of complications', 'timeFrame': '90 days postoperative', 'description': 'Incidence of complications will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COX-2 Inhibitor', 'Meloxicam', 'Stricture Recurrence', 'Direct Vision Internal Urethrotomy']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing urethral stricture recurrence after direct visual internal urethrotomy.', 'detailedDescription': 'The most common aetiology of urethral strictures is idiopathic, followed by iatrogenic causes, including transurethral resection, urethral catheterization, prostate cancer treatments, and previous hypospadias surgery.\n\nThe recurrence rates are higher with previously treated, long and multiple strictures, penile compared with bulbar strictures, and those with perioperative infection.\n\nIt has been reported that post-transurethral resection of the prostate (TURP) to receive or not receive a COX-2 inhibitor (rofecoxib 25 mg/day) for 20 days. At 1 year of follow-up, a urethral stricture had been diagnosed in 17 and 0 % of cases without and with COX-2 treatment, respectively'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Males undergoing direct vision internal urethrotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* American Society of Anesthesiologists (ASA) score ≤3.\n* Urethral stricture length ≤ 1.5 cm\n\nExclusion Criteria:\n\n* Recurrent urethral stricture ≥ 2 times.\n* Pelvic fracture urethral distraction defect (PFUDD).'}, 'identificationModule': {'nctId': 'NCT06697106', 'briefTitle': 'Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?', 'organization': {'class': 'OTHER', 'fullName': 'New Valley University'}, 'officialTitle': 'Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?', 'orgStudyIdInfo': {'id': '20241030012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nonsteroidal anti-inflammatory drugs', 'description': 'Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.', 'interventionNames': ['Drug: Nonsteroidal anti-inflammatory drugs']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nonsteroidal anti-inflammatory drugs', 'type': 'DRUG', 'description': 'Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.', 'armGroupLabels': ['Nonsteroidal anti-inflammatory drugs']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72511', 'city': 'New Valley', 'state': 'New Valley Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Waheed F Abdelrasol, MD', 'role': 'CONTACT', 'email': 'waheed_fawzy@med.nvu.edu.eg', 'phone': '00201207722518'}], 'facility': 'New Valley University'}], 'centralContacts': [{'name': 'Waheed F Abdelrasol, MD', 'role': 'CONTACT', 'email': 'waheed_fawzy@med.nvu.edu.eg', 'phone': '00201207722518'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt', 'investigatorFullName': 'Waheed Fawzy Abdelrasol', 'investigatorAffiliation': 'New Valley University'}}}}