Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-08 @ 1:35 AM
Study NCT ID:
NCT01778660
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2013-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Versus Mnemonic Counseling for Fecal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2013-01-16', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recall', 'timeFrame': 'We are measuring the difference in recall the day of the physician counseling and 2 months after physician counselling', 'description': 'Patients will be asked to recall treatments recommended for fecal incontinence.'}], 'secondaryOutcomes': [{'measure': 'Questionare on the Quality of the Physician and Patient Interaction', 'timeFrame': 'Patients will complete this questionnaire following the physician counseling on day 1 of enrollment.'}, {'measure': 'Modified Manchester', 'timeFrame': 'We are comparing the score change from after the physician counselling on day 1 of enrollment and at 2 month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fecal Incontinence', 'Treatment options', 'Patient Satisfaction'], 'conditions': ['Fecal Incontinence', 'Counselling', 'Patient Satisfaction']}, 'referencesModule': {'references': [{'pmid': '25932833', 'type': 'DERIVED', 'citation': 'Cichowski SB, Dunivan GC, Rogers RG, Murrietta AM, Komesu YM. Standard compared with mnemonic counseling for fecal incontinence: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1063-1070. doi: 10.1097/AOG.0000000000000755.'}]}, 'descriptionModule': {'briefSummary': 'This study compares standard versus mnemonic counseling for the treatment of fecal incontinence. A mnemonic is a word or rhyme used to aid memory. Our hypothesis is that women randomised to mnemonic counseling will higher recall of treatments, satisfaction with the physician visit and greater improvement in their quality of life when compared to women who received standard counseling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n* Diagnosed with fecal incontinence by on of the attending physicians\n* Bothersome fecal incontinence symptoms for at least 3 months\n* Able to give informed consent\n* Able to speak, read and comprehend English\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Fecal Incontinence \\<3 months\n* Unable to give informed consent\n* Unable to speak, read and comprehend English\n* Diagnosis of active colorectal or anal malignancy, inflammatory bowel disease, recto-vaginal fistula, and rectal prolapse'}, 'identificationModule': {'nctId': 'NCT01778660', 'acronym': 'FIT', 'briefTitle': 'Standard Versus Mnemonic Counseling for Fecal Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Standard Versus Mnemonic Counseling for Fecal Incontinence: a Pilot Randomised Control Trial', 'orgStudyIdInfo': {'id': 'CTSC-12-429'}, 'secondaryIdInfos': [{'id': 'CTSTC025-3', 'type': 'OTHER', 'domain': 'CTSC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Counselling', 'description': 'Patients in this arm are randomised to standard counselling.', 'interventionNames': ['Other: Standard']}, {'type': 'EXPERIMENTAL', 'label': 'Mnemonic Counselling', 'description': 'Patients in this arm are randomised to counselling with the aid of a mnemonic.', 'interventionNames': ['Other: Type of Counselling (Mnemonic)']}], 'interventions': [{'name': 'Type of Counselling (Mnemonic)', 'type': 'OTHER', 'armGroupLabels': ['Mnemonic Counselling']}, {'name': 'Standard', 'type': 'OTHER', 'armGroupLabels': ['Standard Counselling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Sara Cichowski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sara Cichowski', 'investigatorAffiliation': 'University of New Mexico'}}}}