Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-03-29 @ 11:19 AM
Study NCT ID:
NCT02042157
Status:
TERMINATED
Last Update Posted:
2017-10-19
First Post:
2014-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007239', 'term': 'Infections'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Equipment malfunction.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-17', 'studyFirstSubmitDate': '2014-01-17', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved quality of life as measured QoL questionnaire', 'timeFrame': '24 months', 'description': 'We are measuring the quality of life using a validated QoL questionnaire which has been slightly modified to include questions around toileting.'}, {'measure': 'Caregiver burden for caregivers of adults with functional limitations as measured by a validated caregiver burden questionnaire.', 'timeFrame': '24 months', 'description': 'We will measure caregiver burden using a validated instrument.'}], 'secondaryOutcomes': [{'measure': 'Incidence of UTI as measured by enquiry and chart review (female patients only).', 'timeFrame': '24 months', 'description': 'Every month we will screen female patients in both arms of the study to ask them if they have had any symptoms of UTI or sought medical attention for UTI.\n\nWe will also review their chart for diagnosis of UTI or prescription of a medication for UTI. Either self-report of a diagnosis or prescription for a medication of a UTI or a report of UTI in the chart will be considered an incidence of UTI.'}, {'measure': 'Incidence of constipation as measured by self report', 'timeFrame': '24 months', 'description': 'We will ask patients on a monthly basis if they have had constipation.'}, {'measure': 'Severity (measured by self report) of constipation', 'timeFrame': '24 months', 'description': 'For those patients who report having had constipation, will ask them to rate the severity of their constipation on a monthly basis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quality of Life', 'Caregivers', 'Caregiver burden', 'Urinary Tract Infections', 'Bidet', "Women's health", 'Toileting', 'Hygiene', 'Activities of Daily Living', 'Functional impairment', 'Geriatrics'], 'conditions': ['Toileting in Adults With Impaired Functional Status', 'Caregiver Burden for Those Who Care for Adults With Impaired Functional Status', 'UTI in Adults With Impaired Functional Status']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://med.stanford.edu/clinicaltrials/', 'label': 'Search engines for all clinical research taking place at Stanford Medical Center'}, {'url': 'http://stanfordhospital.org/forPatients/patientServices/agingAdults/', 'label': 'Portal for Stanford Aging Adult Services'}]}, 'descriptionModule': {'briefSummary': 'Our expectations (hypotheses) are:\n\nPrimary outcome\n\n1. Regular bidet use will improve quality of life around elimination in adults with impaired functional status. Functional status will be measured by activities of daily living (ADL).\n2. Regular bidet use by adults with impaired functional status will improve the quality of life around toileting for their caregivers.\n\n Secondary\n3. Regular bidet use will reduce the incidence, frequency and severity of constipation (as measured by self-report) in adults with impaired functional status.\n4. Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult women with impaired functional status.', 'detailedDescription': 'The study will assess the use of a bidet (a device that is attached to the toilet which allows a person to wash their genitalia after elimination) in improving toilet related quality of life for functionally impaired individuals as measured by ADLs and caregivers of functionally impaired adults. We also want to see if bidet use is effective in lowering the incidence of urinary tract infections in this high risk population.\n\nFunctional impairment around toileting has been shown to negatively impact quality of life (QOL) for both patients and their caregivers. We hope to learn if the use of bidet will improve QOL in this population.\n\nUrinary tract infections increase the risk of morbidity and mortality in women with impaired functional status. Specifically the risk of hospitalization, sepsis, kidney failure and other complications. There are not currently effective forms of non-pharmaceutical prevention. Bidets are safe, inexpensive and hygienic. Individuals with functional impairment often have difficulty maintaining their hygiene due to frailty and functional limitations. It is our hope that addressing these issues will lead to a reduced incidence of UTI.\n\nConstipation is a common problem in elderly adults and in adults with impaired functional status. It is our hope that the bidet will reduce the frequency and severity of constipation (as measured by self report).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSample 1 (adults with impaired functional status):\n\nAge: 55-95 Sex: Female Ethic background: Reflecting the population at Stanford Hospital and Clinics who meet the inclusion criteria and who agree to participate.\n\nSample 2 (caregivers of participants in Sample 1) Adults over the age of 21 caring for an adult with impaired functional status who has enrolled in this randomized controlled trial. Sex and ethnic background will reflect the demographic of the caregivers for the population in Sample 1.\n\nExclusion Criteria:\n\nParticipants not meeting the inclusion criteria.\n\nAdditional exclusion criteria:\n\n1. Life expectancy less than 2 years\n2. The inability to read and write English.\n3. Patients with indwelling urinary (e.g. Foley) catheters\n4. Use of any water based cleaning system after toileting at home in the past 12 months (bidet, water pot, douche etc).\n5. Fully incontinent (eg diaper use)\n6. Moderate to severe cognitive impairment (15 or lower on the MOCA)'}, 'identificationModule': {'nctId': 'NCT02042157', 'briefTitle': 'Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting', 'orgStudyIdInfo': {'id': 'IRB-22588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bidet use', 'description': 'This arm will have a bidet installed in their home bathroom and be instructed how to use it. This arm will use the bidet for usual toileting for a period of two years.', 'interventionNames': ['Behavioral: Bidet use']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Toileting', 'description': 'This group will toilet as usual.', 'interventionNames': ['Other: Regular toileting']}, {'type': 'EXPERIMENTAL', 'label': 'Caregivers of PT in Arm 1 (bidet use)', 'description': 'Participants with functional impairment will be randomized into one of two arms (bidet use or usual toileting). Their caregivers will be enrolled and their randomization is "bundled" with the study participant who they care for. This arm will care for participants who have been randomized to bidet.', 'interventionNames': ['Behavioral: Bidet use']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Caregivers of PT in Arm 2 (usual toileting)', 'description': 'Participants with functional impairment will be randomized into one of two arms (bidet use or usual toileting). Their caregivers will be enrolled and their randomization is "bundled" with the study participant who they care for. This arm will care for participants who have been randomized to usual toileting.', 'interventionNames': ['Other: Regular toileting']}], 'interventions': [{'name': 'Bidet use', 'type': 'BEHAVIORAL', 'description': 'Participants used a bidet, a device installed on the toilet that provides fresh water to help clean the bottom and genitalia after having a bowel movement or urinating.', 'armGroupLabels': ['Bidet use', 'Caregivers of PT in Arm 1 (bidet use)']}, {'name': 'Regular toileting', 'type': 'OTHER', 'description': 'Patients in the control arm will toilet as usual.', 'armGroupLabels': ['Caregivers of PT in Arm 2 (usual toileting)', 'Usual Toileting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Yusra Hussain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark Cullen', 'investigatorAffiliation': 'Stanford University'}}}}