Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-04 @ 4:04 PM
Study NCT ID:
NCT01666405
Status:
TERMINATED
Last Update Posted:
2015-10-29
First Post:
2012-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': '18 weeks', 'description': 'To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline'}, {'measure': 'Safety', 'timeFrame': '18 weeks', 'description': 'To characterize adverse events experienced throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fecal Incontinence', 'Bowel Incontinence'], 'conditions': ['Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).', 'detailedDescription': 'Pilot Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter)\n* Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.)\n\nExclusion Criteria:\n\n* Pregnancy or intention to become pregnant during the course of the study\n* Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.)\n* Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function\n* Prone to excessive bleeding or bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT01666405', 'briefTitle': 'Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uroplasty, Inc'}, 'officialTitle': 'A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence', 'orgStudyIdInfo': {'id': 'UPC032012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Urgent(R) PC Neuromodulation System', 'description': 'Urgent(R) PC Neuromodulation System', 'interventionNames': ['Device: Urgent(R) PC Neuromodulation System']}], 'interventions': [{'name': 'Urgent(R) PC Neuromodulation System', 'type': 'DEVICE', 'description': 'The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS).', 'armGroupLabels': ['Urgent(R) PC Neuromodulation System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Center for Colorectal Surgery', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Colon and Rectal Surgery Associates, Ltd.', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Center for Research and Education at The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Colorectal Surgical Asociates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Health and Services', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uroplasty, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}