Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-03 @ 1:28 AM
Study NCT ID:
NCT00467467
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2007-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C047638', 'term': 'alfuzosin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-28', 'studyFirstSubmitDate': '2007-04-27', 'studyFirstSubmitQcDate': '2007-04-27', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of study medication on urinary symptoms and quality of life'}, {'measure': 'usage of analgesics/narcotics'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ureteral Stent Discomfort']}, 'descriptionModule': {'briefSummary': 'To assess the impact of alfuzosin vs. placebo on ureteral stent discomfort, urinary symptoms and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18\n* Undergoing unilateral retrograde ureteroscopy with ureteral stent placement\n\nExclusion Criteria:\n\n* Significant ureteral trauma\n* Concomitant ESWL or other secondary surgical procedure than may impact patient comfort\n* Subject with know hypersensitivity to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets.\n* Pregnancy, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study\n* Undergoing bilateral ureteral stenting\n* Undergoing antegrade ureteral stenting\n* Undergoing simultaneous extracorporeal shockwave lithotripsy\n* Urinary infection (fever \\>101, positive urine culture, many bacteria on urinalysis)\n* Primary bladder dysfunction that would impact ability to void without a catheter\n* Neurologic dysfunction that would impair pain sensation\n* History of chronic pain or substance abuse\n* Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased\n* Other alpha-blockers\n* Phosphodiesterase type 5 inhibitors for erectile function Any subject for whom the principal investigator feels it would not be in his or her best interest to participate in the study.'}, 'identificationModule': {'nctId': 'NCT00467467', 'briefTitle': 'Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Alfuzosin Hydrochloride to Relieve Ureteral Stent Discomfort', 'orgStudyIdInfo': {'id': '0512M78807'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alfuzosin Hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Manoj Monga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}}}}