Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT00292318
Status:
TERMINATED
Last Update Posted:
2015-08-19
First Post:
2006-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Patients With Fecal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'felix.leung@va.gov', 'phone': '818-891-7711', 'title': 'Felix W. Leung, MD', 'phoneExt': '9403', 'organization': 'Greater Los Angeles VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.\n\ncontrol group: Medical counseling and ano-sphinctal exercises.', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Study Grp/Biofeedback', 'description': 'Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.\n\nBiofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Report of "Adequate Relief" From FI Symptoms With a "Yes" Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A "Responder" Will be Defined as One Who Provides a "Yes" Answer.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.\n\ncontrol group: Medical counseling and ano-sphinctal exercises.'}, {'id': 'OG001', 'title': 'Study Grp/Biofeedback', 'description': 'Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.\n\nBiofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.', 'description': 'Only reporting the results of participants who reported adequate relief.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants that completed the full number of study visits were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.\n\ncontrol group: Medical counseling and ano-sphinctal exercises.'}, {'id': 'OG001', 'title': 'Study Grp/Biofeedback', 'description': 'Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.\n\nBiofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.'}], 'timeFrame': 'The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.', 'description': 'Measurement of pressure changes by a colonoscope as recorded by a manometric catheter connected to a Polygraph transducer.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected due medical instruments to measure this outcome were removed by VA staff causing the study to be terminated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.\n\ncontrol group: Medical counseling and ano-sphinctal exercises.'}, {'id': 'FG001', 'title': 'Study Grp/Biofeedback', 'description': 'Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.\n\nBiofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study terminated by officials', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.\n\ncontrol group: Medical counseling and ano-sphinctal exercises.'}, {'id': 'BG001', 'title': 'Study Grp/Biofeedback', 'description': 'Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.\n\nBiofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.'}, {'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': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', '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': '3', 'groupId': 'BG001'}, {'value': '7', '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': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Unable to continue due to medical equipment necessary for research study was removed from facility.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2006-02-13', 'resultsFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2006-02-13', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-13', 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Report of "Adequate Relief" From FI Symptoms With a "Yes" Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A "Responder" Will be Defined as One Who Provides a "Yes" Answer.', 'timeFrame': 'The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.', 'description': 'Only reporting the results of participants who reported adequate relief.'}], 'secondaryOutcomes': [{'measure': 'Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure)', 'timeFrame': 'The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.', 'description': 'Measurement of pressure changes by a colonoscope as recorded by a manometric catheter connected to a Polygraph transducer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adequate relief', 'anorectal manometry', 'biofeedback therapy', 'fecal incontinence'], 'conditions': ['Fecal Incontinence']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aboutincontinence.org/', 'label': 'One of the family of web sites by the international Organization for Functional Gastrointestinal Disorders (IFFGD)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a behavioral treatment method called biofeedback will reduce the frequency of episodes of leakage of fecal material in patient suffering from fecal incontinence.', 'detailedDescription': "Fecal incontinence (FI) is a devastating condition that causes psychological stress, shame, embarrassment, and social isolation. It has a major impact on quality of life of patients and their families. It complicates medical illnesses and management, has major economic consequences and can contribute to early nursing home placement. Although FI affects 2.2% to 11% of the general population, the magnitude of the problem is underestimated, since most patients do not discuss this silent affliction with their care providers. In uncontrolled studies of biofeedback for FI, including our preliminary observations in male veterans without anal sphincter injury, improvement was observed in up to 80% of patients. However, it may not be appropriate for all patients. One recent randomized, controlled trial in predominantly (93% women) female patients, many (\\> 60%) with post-obstetrical anal sphincter injury, reports that biofeedback is no more effective than medical therapy alone. The trial provides data for the formulation of an evidence-based approach to treat FI in female veterans. There are no randomized, controlled data on the effectiveness of biofeedback for FI in male patients. A randomized, controlled trial is needed to assess the effectiveness of multi-component biofeedback therapy versus standard medical therapy in man. The immediate objectives of the current proposal are to evaluate the effectiveness of biofeedback treatment for FI and to identify baseline patient characteristics that will predict improvement and adequate relief in FI symptoms following treatment. This will lead directly to our long-term goal of providing optimal treatment for FI by tailoring biofeedback plus medical therapy to each patient's needs, based on sound clinical evidence. This project is a prospective, randomized, controlled clinical trial comparing two treatments for FI among patients who have failed medical treatment under the care of their primary care providers and are referred for evaluation and management of current FI. As part of standard care, all referred patients will receive a history and physical examination, including medical, surgical, FI-specific symptoms and physical findings (general, mobility, mental status and anorectal examination). Those who meet inclusion criteria and who agree to participate will be randomly assigned to one of 2 study arms: 1. medical therapy alone, 2. medical therapy + sphincter strength + sensation + coordination training. Baseline data will also include adequate relief measure, incontinence scores based on bowel habit diary, anorectal parameters based on manometric and sensory testing, general and FI-specific quality of life, depression, anxiety, and expectation of improvement following treatment. All questionnaires will be based on published, validated instruments. Patients will be treated in six biweekly sessions (3 months). Medical therapy (six 40 - 60 minute sessions) includes advice, medication for constipation/diarrhea, and instruction related to empiric anal sphincter exercises (group 1). Biofeedback treatment (six 40 - 60 minute sessions) includes medical therapy plus all components of biofeedback (groups 2). Follow up data will be obtained in all patients at the end of treatment (3 months) and by mailed questionnaires at 12 months after completion of treatment or dropout. We can determine if biofeedback plus medical therapy will be superior to medical therapy alone in providing FI symptom relief. The possibility that more patients will report relief of FI symptoms when specific deficit(s) detected at baseline testing show(s) improvement with treatment. The influence of co-variables on results of treatment can also be determined. Our long term goal is to develop a clinically relevant strategy that will be cost-effect for the management of FI in VA patients (predominantly male) within the organizational frame work of primary and subspecialty care. If biofeedback treatment is proven to be effective, and VA patients can be offered therapy components with optimal likelihood of success, the obvious benefit to our VA patients is abatement of the silent affliction of FI and improvement in patient satisfaction and quality of life. Further study will focus on a multi-site cooperative study to assess which component of biofeedback is most instrumental in bringing about improvement and relief in patients with specific deficits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or female patient with inadequate relief of fecal incontinence symptoms after documented management in the primary care setting. They must have:\n\n* a mini-mental status score of \\> 18\n* an "up and go" test score of \\< 30 seconds\n* bowel habit diary showing \\> one episode of fecal incontinence episode per week\n\nExclusion Criteria:\n\n* patients who previously underwent a course of biofeedback for fecal incontinence\n* age \\< 18 years\n* major neurological disease\n* significant cognitive impairment (mini mental status examination score \\< 18), functional impairment (up and go score of \\> 30 seconds)\n* active inflammatory bowel disease\n* history of spinal cord injury\n* rectal resection\n* ileal pouch procedures\n* latex allergy\n* significantly distressed and unable to consider informed consent issues adequately\n* needing urgent medical referral\n* insufficient written English skills to complete the questionnaires\n* require surgery'}, 'identificationModule': {'nctId': 'NCT00292318', 'briefTitle': 'Treatment of Patients With Fecal Incontinence', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Biofeedback Therapy for Fecal Incontinence a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'CLIN-013-05S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.', 'interventionNames': ['Behavioral: control group']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.', 'interventionNames': ['Behavioral: Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study']}], 'interventions': [{'name': 'Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study', 'type': 'BEHAVIORAL', 'description': 'Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.', 'armGroupLabels': ['Arm 2']}, {'name': 'control group', 'type': 'BEHAVIORAL', 'description': 'Medical counseling and ano-sphinctal exercises.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91343', 'city': 'Sepulveda', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, Sepulveda, CA', 'geoPoint': {'lat': 34.16167, 'lon': -118.28285}}], 'overallOfficials': [{'name': 'Felix W Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, Sepulveda, CA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}