Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT01381120
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2010-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D021501', 'term': 'Flank Pain'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D053158', 'term': 'Nocturia'}, {'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069464', 'term': 'Solifenacin Succinate'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joezadra@rogers.com', 'title': 'Dr. Joseph Zadra', 'organization': 'Barrie Urology Associates'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for the duration of the study (October 2010 - June 2012)', 'description': 'Non-serious events were not recorded. Patients were encouraged to contact the study coordinator if they experienced any serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'VESIcare + Narcotic Painkiller', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Narcotic Painkiller', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Post-ureteroscopy Stent-induced Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VESIcare + Narcotic Painkiller', 'description': 'VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)'}, {'id': 'OG001', 'title': 'Narcotic Painkiller', 'description': 'Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.61', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '5.46'}, {'value': '3.11', 'groupId': 'OG001', 'lowerLimit': '1.63', 'upperLimit': '4.60'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months.', 'description': 'Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VESIcare + Narcotic Painkiller', 'description': 'VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)'}, {'id': 'OG001', 'title': 'Narcotic Painkiller', 'description': 'Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.90', 'groupId': 'OG000', 'lowerLimit': '1.60', 'upperLimit': '2.21'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.82', 'upperLimit': '1.43'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and three months.', 'description': 'Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VESIcare + Narcotic Painkiller'}, {'id': 'FG001', 'title': 'Narcotic Painkiller'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VESIcare + Narcotic Painkiller'}, {'id': 'BG001', 'title': 'Narcotic Painkiller'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.81', 'spread': '12.36', 'groupId': 'BG000'}, {'value': '57.54', 'spread': '18.73', 'groupId': 'BG001'}, {'value': '53', 'spread': '15.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2010-09-02', 'resultsFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-18', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Post-ureteroscopy Stent-induced Pain', 'timeFrame': 'Baseline and 3 months.', 'description': 'Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.', 'timeFrame': 'Baseline and three months.', 'description': 'Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Flank Pain', 'Lower Urinary Tract Symptoms', 'LUTS', 'Urgency', 'Nocturia', 'Frequency', 'Ureteroscopy', 'Kidney Stones', 'Stent', 'Incontinence', 'VESIcare', 'Ureter', 'Urinary Bladder, Overactive', 'OAB', 'Overactive Bladder Syndrome'], 'conditions': ['Flank Pain', 'Urinary Bladder, Overactive']}, 'referencesModule': {'references': [{'pmid': '20425092', 'type': 'BACKGROUND', 'citation': 'Mendez-Probst CE, Fernandez A, Denstedt JD. Current status of ureteral stent technologies: comfort and antimicrobial resistance. Curr Urol Rep. 2010 Mar;11(2):67-73. doi: 10.1007/s11934-010-0091-y.'}, {'pmid': '19277623', 'type': 'BACKGROUND', 'citation': 'Wang CJ, Huang SW, Chang CH. Effects of specific alpha-1A/1D blocker on lower urinary tract symptoms due to double-J stent: a prospectively randomized study. Urol Res. 2009 Jun;37(3):147-52. doi: 10.1007/s00240-009-0182-8. Epub 2009 Mar 10.'}, {'pmid': '18338955', 'type': 'BACKGROUND', 'citation': "Damiano R, Autorino R, De Sio M, Giacobbe A, Palumbo IM, D'Armiento M. Effect of tamsulosin in preventing ureteral stent-related morbidity: a prospective study. J Endourol. 2008 Apr;22(4):651-6. doi: 10.1089/end.2007.0257."}, {'pmid': '19814699', 'type': 'BACKGROUND', 'citation': 'Park SC, Jung SW, Lee JW, Rim JS. The effects of tolterodine extended release and alfuzosin for the treatment of double-j stent-related symptoms. J Endourol. 2009 Nov;23(11):1913-7. doi: 10.1089/end.2009.0173.'}, {'pmid': '12576846', 'type': 'BACKGROUND', 'citation': 'Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.'}]}, 'descriptionModule': {'briefSummary': 'Most ureteral stent insertions follow ureteroscopy procedures for stone management. Stents are essentially designed to prevent the blockage of the ureter. Such blockage is often a result of inflammation caused by ureteroscopy procedures. The stent provides a secure passageway for urine as it travels from the kidneys to the bladder, circumventing potential urinary retention. In our community, only one kind of stent is used, and it is manufactured by Bard. Standard protocol involves the removal of the stent 5 to 8 days following insertion. If stenting is required for greater than 8 days, special accommodations will be made for you in this study.\n\nUnfortunately, pain and lower urinary tract symptoms are often associated with the insertion and removal of stents. It is our goal to determine whether VESIcare is capable of relieving such symptoms.\n\nAs a prospective member of this study, you will be asked to complete three surveys. The first survey will ask you about your experiences of urinary urgency and pain before your surgery. If you are an emergency patient, you will be asked to remember your condition before the surgery, completing this questionnaire at your first post-op visit. If you are not an emergency patient, this survey will be completed before your surgery. If your stent is removed within 5 to 8 days of surgery, you will be asked to complete the second survey at the time of removal. You will then complete the final survey at a scheduled post-operative check-up 4 to 5 weeks later. If your stent remains inserted for greater than 8 days after surgery, you will be asked to complete the second survey 3 to 4 days after your stent was inserted. You will then complete the final survey, 7 to 8 weeks post-op.\n\nThroughout this study, both VESIcare and non-VESIcare patients will be important in determining whether VESIcare truly is capable of relieving stent pain. As such, you will be randomly assigned to one of the two groups, those receiving VESIcare, and those who are not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Subject inclusion criteria.\n\n1. Post-ureteroscopy for stone management.\n2. Stent inserted for more than 5 days.\n3. No significant flank pain or LUTS prior to kidney stones/stent insertion.\n4. Complete agreement with and signing of Informed Consent form.\n\nSubject exclusion criteria.\n\n1. Significant flank pain or LUTS prior to kidney stones/stent insertion.\n2. Currently taking antimuscarinics or α1 blockers.\n3. Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.'}, 'identificationModule': {'nctId': 'NCT01381120', 'briefTitle': 'Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Barrie Urology Associates'}, 'officialTitle': 'Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (LUTS) Post Ureteroscopy for Stone Management', 'orgStudyIdInfo': {'id': 'ARC-2010-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VESIcare + Narcotic Painkiller', 'description': 'VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)', 'interventionNames': ['Drug: Solifenacin succinate treatment', 'Drug: Oxycodone and acetaminophen combination treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Narcotic Painkiller', 'description': 'Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)', 'interventionNames': ['Drug: Oxycodone and acetaminophen combination treatment']}], 'interventions': [{'name': 'Solifenacin succinate treatment', 'type': 'DRUG', 'otherNames': ['VESIcare'], 'description': 'Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months', 'armGroupLabels': ['VESIcare + Narcotic Painkiller']}, {'name': 'Oxycodone and acetaminophen combination treatment', 'type': 'DRUG', 'description': 'Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)', 'armGroupLabels': ['Narcotic Painkiller', 'VESIcare + Narcotic Painkiller']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L4M 7G1', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Barrie Urology Associates - The Male/Female Health and Research Centre', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}], 'overallOfficials': [{'name': 'Joseph A Zadra, MD CM FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barrie Urology Associates - The Male/Female Health and Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barrie Urology Associates', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma Canada, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Urology, RVH', 'investigatorFullName': 'Dr. Joseph Zadra', 'investigatorAffiliation': 'Barrie Urology Associates'}}}}