Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-27 @ 2:28 PM
Study NCT ID:
NCT03750656
Status:
TERMINATED
Last Update Posted:
2024-12-03
First Post:
2018-11-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064692', 'term': 'Hyoscyamine'}, {'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D001285', 'term': 'Atropine'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dduchene@kumc.edu', 'phone': '(913) 588-8721', 'title': 'Dr. David Duchene', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Not Applicable - Adverse events were not documented.', 'description': 'Study was terminated early therefore no data was collected to monitor/assess adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Hyoscyamine', 'description': 'Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort\n\nHyoscyamine: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tamsulosin', 'description': '0.4 mg tab orally daily\n\nTamsulosin: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ureteral Stent Symptom Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyoscyamine', 'description': 'Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort\n\nHyoscyamine: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent'}, {'id': 'OG001', 'title': 'Tamsulosin', 'description': '0.4 mg tab orally daily\n\nTamsulosin: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent'}], 'timeFrame': 'Three Years', 'description': 'To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected to complete data analysis for the patients enrolled.'}, {'type': 'SECONDARY', 'title': 'Additional Medication Needed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyoscyamine', 'description': 'Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort\n\nHyoscyamine: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent'}, {'id': 'OG001', 'title': 'Tamsulosin', 'description': '0.4 mg tab orally daily\n\nTamsulosin: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent'}], 'timeFrame': 'Three Years', 'description': 'To determine if there is a difference between the amount of additional medications needed to treat stent related discomfort between patients receiving hyoscyamine versus those that receive tamsulosin', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected to complete data analysis for the patients enrolled.'}, {'type': 'SECONDARY', 'title': 'Factors That Determine if Additional Medication Needed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyoscyamine', 'description': 'Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort\n\nHyoscyamine: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent'}, {'id': 'OG001', 'title': 'Tamsulosin', 'description': '0.4 mg tab orally daily\n\nTamsulosin: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent'}], 'timeFrame': 'Three Years', 'description': 'To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected to complete data analysis for the patients enrolled.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hyoscyamine', 'description': 'Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort\n\nHyoscyamine: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent'}, {'id': 'FG001', 'title': 'Tamsulosin', 'description': '0.4 mg tab orally daily\n\nTamsulosin: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hyoscyamine', 'description': 'Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort\n\nHyoscyamine: Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent'}, {'id': 'BG001', 'title': 'Tamsulosin', 'description': '0.4 mg tab orally daily\n\nTamsulosin: Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-16', 'size': 341463, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-12T15:28', 'hasProtocol': True}, {'date': '2020-05-22', 'size': 257468, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-12T15:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized open-blind clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Not accruing patients quickly enough', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2018-11-16', 'resultsFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-12', 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ureteral Stent Symptom Questionnaire Score', 'timeFrame': 'Three Years', 'description': 'To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).'}], 'secondaryOutcomes': [{'measure': 'Additional Medication Needed', 'timeFrame': 'Three Years', 'description': 'To determine if there is a difference between the amount of additional medications needed to treat stent related discomfort between patients receiving hyoscyamine versus those that receive tamsulosin'}, {'measure': 'Factors That Determine if Additional Medication Needed', 'timeFrame': 'Three Years', 'description': 'To determine factors contributing to patients needing additional medication for treatment of stent-related discomfort'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Urinary Tract Symptoms']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents.', 'detailedDescription': 'Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately, indwelling ureteral stents commonly cause significant pain and discomfort due to irritation to the urinary system. Many studies have looked at methods to reduce these uncomfortable symptoms ranging from altering stent designs to pharmacologic therapies attempting to alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is often the cause of their removal earlier than planned. While the efficacy of certain alpha blockers and anticholinergics in treating stent-related symptoms have been studied, the data for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm will not require additional pain medications (e.g. Pyridium, narcotics) to help control stent-related discomfort compared to the tamsulosin arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 18 years of age or older\n* Patient must require placement of a ureteral stent(s), per standard of care, following routine urological procedures including, but not limited to, ureteroscopy, stone extraction, or management of upper tract transitional cell carcinoma\n* Patient must agree to abstain from other clinical studies during the study period\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Patients with chronic or pre-existing indwelling stents\n* Patients currently receiving anticholinergic or alpha blocker therapy\n* Patients with chronic opioid or analgesic usage\n* Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia\n* Patients with an active untreated urinary tract infection\n* Patients who are currently pregnant or nursing\n* Patients with allergies or contraindication to either tamsulosin or hyoscyamine\n* Patients on active chemotherapy\n* Patients currently receiving other investigational therapy\n* Patients who are unable to sign consent/answer questionnaire due to compromised mental capacity or language barrier (the questionnaire is not validated in other languages)\n* Patients who have a stent placed emergently for an obstructing stone or septic stone without immediate stone removal,\n* Any stents placed that will stay in for longer than 2 weeks'}, 'identificationModule': {'nctId': 'NCT03750656', 'acronym': 'HyTa Stent', 'briefTitle': 'Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation', 'orgStudyIdInfo': {'id': 'HSC 142994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hyoscyamine', 'description': 'Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort', 'interventionNames': ['Drug: Hyoscyamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin', 'description': '0.4 mg tab orally daily', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'Hyoscyamine', 'type': 'DRUG', 'description': 'Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent', 'armGroupLabels': ['Hyoscyamine']}, {'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent', 'armGroupLabels': ['Tamsulosin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David Duchene, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}