Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-01-01 @ 8:09 PM
Study NCT ID:
NCT00928395
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'megan.otoole@uroplasty.com', 'phone': '952-426-6153', 'title': 'Clinical Study Manager', 'organization': 'Uroplasty, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Urgent PC', 'description': 'The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).', 'otherNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bleeding at needle site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Urgent PC', 'description': 'The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).'}], 'classes': [{'categories': [{'measurements': [{'value': '.77', 'groupId': 'OG000', 'lowerLimit': '.64', 'upperLimit': '.90'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months total', 'description': 'The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).', 'unitOfMeasure': 'Proportion of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.', 'timeFrame': 'every three months for 36 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in OAB-q and SF-36 Questionnaires.', 'timeFrame': 'every three months for 36 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Voiding Diary Parameters.', 'timeFrame': 'every three months for 36 months', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Urgent PC', 'description': 'The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'Subjects were recruited by investigator sites.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Urgent PC', 'description': 'The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '15.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-04', 'studyFirstSubmitDate': '2009-06-24', 'resultsFirstSubmitDate': '2013-01-24', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-04', 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline', 'timeFrame': '36 months total', 'description': 'The GRA asked patients, "Compared to the last time you completed this questionnaire, how would you rate your bladder symptoms now?" and was a 7-level Assessment (markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse, markedly worse).'}], 'secondaryOutcomes': [{'measure': 'GRA Subset of Individual Bladder Symptom Components to Include Urgency, Frequency and Urge Incontinence.', 'timeFrame': 'every three months for 36 months'}, {'measure': 'Change in OAB-q and SF-36 Questionnaires.', 'timeFrame': 'every three months for 36 months'}, {'measure': 'Change in Voiding Diary Parameters.', 'timeFrame': 'every three months for 36 months'}]}, 'conditionsModule': {'keywords': ['Urgent PC', 'Overactive Bladder', 'SUmiT Trial', 'Overactive Urinary Bladder'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'references': [{'pmid': '22674493', 'type': 'DERIVED', 'citation': 'Peters KM, Carrico DJ, MacDiarmid SA, Wooldridge LS, Khan AU, McCoy CE, Franco N, Bennett JB. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourol Urodyn. 2013 Jan;32(1):24-9. doi: 10.1002/nau.22266. Epub 2012 Jun 5.'}]}, 'descriptionModule': {'briefSummary': 'This is a modified extension study to the SUmiT protocol UPC082008 (NCT00534521) to observe and evaluate long term therapy with PTNS on overactive bladder symptoms. Subjects must have completed the 12 weekly treatments of the original protocol, the 13 week follow up assessment, be randomized to the PTNS arm, and be considered a positive responder with moderate or marked improvement in the SUmiT Trial to be enrolled in this study. All consenting responders will continue with active PTNS therapy at an initially prescribed protocol for approximately 3 months followed by individualized symptom-based frequency of visits as determined by the subject along with their treating clinician, for up to a total of 33 months post initial 12-week therapy for a total of 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial\n* Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial\n* Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA\n* Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial\n* Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial\n* Subjects must remain off all antimuscarinics throughout participation in trial\n* Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008\n* Capable of giving informed consent\n* Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years\n\nExclusion Criteria:\n\n* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period\n* Subjects who were not able or willing to follow original SUmiT Trial study schedule'}, 'identificationModule': {'nctId': 'NCT00928395', 'acronym': 'STEP', 'briefTitle': 'Modified Extension Study to the SUmiT Trial: Evaluation of Long Term Therapy With Percutaneous Tibial Nerve Stimulation (PTNS) for Overactive Bladder Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uroplasty, Inc'}, 'officialTitle': 'Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation', 'orgStudyIdInfo': {'id': 'UPC121908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Urgent PC', 'description': 'The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).', 'interventionNames': ['Device: Urgent PC']}], 'interventions': [{'name': 'Urgent PC', 'type': 'DEVICE', 'description': 'The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).', 'armGroupLabels': ['Urgent PC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95928', 'city': 'Chico', 'state': 'California', 'country': 'United States', 'facility': 'Gregory L. Davis, M.D., FACOG, Inc.', 'geoPoint': {'lat': 39.72849, 'lon': -121.83748}}, {'zip': '06830', 'city': 'Greenwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Greenwich Urological Associates, P.C.', 'geoPoint': {'lat': 41.02649, 'lon': -73.62846}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Specialists in Urology', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Grand Rapids Women's Health DBA Female Pelvic Medicine & Urogynecology Institue of Michigan", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49444', 'city': 'Muskegon', 'state': 'Michigan', 'country': 'United States', 'facility': 'Mercy Health Partners at the Lakes', 'geoPoint': {'lat': 43.23418, 'lon': -86.24839}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '68025', 'city': 'Fremont', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Urology Health Center, PC', 'geoPoint': {'lat': 41.43333, 'lon': -96.49808}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Capital Region Urological Surgeons, PLLC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10604', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': "Central Missouri Women's Healthcare, LLC", 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Alliance Urology Specialists', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Urology', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98027', 'city': 'Issaquah', 'state': 'Washington', 'country': 'United States', 'facility': 'Athena Urology', 'geoPoint': {'lat': 47.5301, 'lon': -122.03262}}], 'overallOfficials': [{'name': 'Kenneth Peters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beaumont Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uroplasty, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}