Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT01764893
Status:
TERMINATED
Last Update Posted:
2014-05-23
First Post:
2013-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-04-02', 'releaseDate': '2015-03-22'}], 'estimatedResultsFirstSubmitDate': '2015-03-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069464', 'term': 'Solifenacin Succinate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-22', 'studyFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2013-01-08', 'lastUpdatePostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overactive Bladder Questionnaire, items 1-8 only', 'timeFrame': 'Change from Baseline in Overactive Bladder Questionnaire at 11 weeks.'}, {'measure': 'Overactive Bladder Questionnaire, items 1-8 only', 'timeFrame': 'Change from Baseline in Overactive Bladder Questionnaire at 15 weeks.'}], 'secondaryOutcomes': [{'measure': '3-day micturition diary', 'timeFrame': 'Change in Bladder diary from Baseline to 5 weeks.', 'description': 'To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)'}, {'measure': '3-day micturition diary', 'timeFrame': 'Change in Bladder diary from Baseline to 11 weeks.', 'description': 'To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)'}, {'measure': '3-day micturition diary', 'timeFrame': 'Change in Bladder diary from Baseline to 15 weeks.', 'description': 'To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)'}, {'measure': 'Urgency Perception Scale (questionnaire)', 'timeFrame': 'Changes in Urgency Perception from Baseline to 11 weeks.'}, {'measure': 'Urgency Perception Scale (questionnaire)', 'timeFrame': 'Changes in Urgency Perception from Baseline to 15 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Overactive Bladder'], 'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age or older\n2. history of overactive bladder\n3. history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication\n4. PTNS-naive\n5. willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")\n6. able to swallow and retain oral medication\n7. able and willing to participate in the full duration of the study\n8. able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent\n9. OAB-q (items 1-8) score of 30 or higher\n\nExclusion Criteria:\n\n1. presence of cardiac pacemaker and/or defibrillator\n2. history of urinary retention\n3. history of gastric retention\n4. uncontrolled narrow angle glaucoma\n5. any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction,coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 3 months prior to Screening visit\n6. abnormal liver function test (greater than 3 times the upper limit of normal for alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], or alkaline phosphatase \\[ALP\\]); or bilirubin \\> 3 times the upper limit of normal\n7. history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject\n8. known hypersensitivity to solifenacin\n9. participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or any time during the study period\n10. pregnancy or trying to become pregnant\n11. breast-feeding'}, 'identificationModule': {'nctId': 'NCT01764893', 'briefTitle': 'Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Bay State Clinical Trials, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Solifenacin and Percutaneous Tibial Nerve Stimulation in Patients With Refractory Overactive Bladder', 'orgStudyIdInfo': {'id': 'BSU-SOL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PTNS and solifenacin', 'description': 'PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks', 'interventionNames': ['Other: PTNS plus solifenacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PTNS and placebo', 'description': 'PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'PTNS plus solifenacin', 'type': 'OTHER', 'otherNames': ['Vesicare'], 'description': '12 weekly treatments with percutaneous tibial nerve stimulation with 5 mg of solifenacin; an additional 4 weeks of solifenacin for a total of 15 weeks of study drug.', 'armGroupLabels': ['PTNS and solifenacin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.', 'armGroupLabels': ['PTNS and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Bay State Clinical Trials, Inc.', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}], 'overallOfficials': [{'name': 'H. David Mitcheson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bay State Clinical Trials, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bay State Clinical Trials, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-03-22', 'type': 'RELEASE'}, {'date': '2015-04-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bay State Clinical Trials, Inc.'}}}}