Toileting in Adults With Impaired Functional StatusNCT02042157
Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
A study testing Bidet use and Regular toileting in people with Toileting in Adults With Impaired Functional Status and Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, run by Stanford University at 1 site in United States.
Trial summary
Our expectations (hypotheses) are: Primary outcome 1. 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). 2. Read more about this study
- Who is it for?
- Ages 21 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- Bidet use and Regular toileting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sample 1 (adults with impaired functional status):
- Age: 55-95 Sex: Female Ethic background: Reflecting the population at Stanford Hospital and Clinics who meet the inclusion criteria and who agree to participate.
- Sample 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.
Who cannot join
- Participants not meeting the inclusion criteria.
- Additional exclusion criteria:
- Life expectancy less than 2 years
- The inability to read and write English.
- Patients with indwelling urinary (e.g. Foley) catheters
- Use of any water based cleaning system after toileting at home in the past 12 months (bidet, water pot, douche etc).
- Fully incontinent (eg diaper use)
- Moderate to severe cognitive impairment (15 or lower on the MOCA)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Our expectations (hypotheses) are:
Primary outcome
- 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).
- Regular bidet use by adults with impaired functional status will improve the quality of life around toileting for their caregivers. Secondary
- Regular bidet use will reduce the incidence, frequency and severity of constipation (as measured by self-report) in adults with impaired functional status.
- Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult women with impaired functional status.
Read the detailed description
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.
Functional 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.
Urinary 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.
Constipation 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).
- 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
- Being tested
- Bidet use, Regular toileting
- Keywords
- Quality of Life, Caregivers, Caregiver burden, Urinary Tract Infections, Bidet, Women's health, Toileting, Hygiene, Activities of Daily Living, Functional impairment, Geriatrics
- Medical subject headings
- Caregiver Burden, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bidet useBehavioural
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.
Regular toiletingOther
Patients in the control arm will toilet as usual.
| Study group | Role | What they receive |
|---|---|---|
| Bidet use | Experimental | 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. Receives: Behavioral: Bidet use |
| Usual Toileting | Placebo comparator | This group will toilet as usual. Receives: Other: Regular toileting |
| Caregivers of PT in Arm 1 (bidet use) | Experimental | 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. Receives: Behavioral: Bidet use |
| Caregivers of PT in Arm 2 (usual toileting) | Placebo comparator | 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. Receives: Other: Regular toileting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved quality of life as measured QoL questionnaire
We are measuring the quality of life using a validated QoL questionnaire which has been slightly modified to include questions around toileting.
Measured: 24 months
Caregiver burden for caregivers of adults with functional limitations as measured by a validated caregiver burden questionnaire.
We will measure caregiver burden using a validated instrument.
Measured: 24 months
Secondary outcomes (3)
Incidence of UTI as measured by enquiry and chart review (female patients only).
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.
We 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.
Measured: 24 months
Incidence of constipation as measured by self report
We will ask patients on a monthly basis if they have had constipation.
Measured: 24 months
Severity (measured by self report) of constipation
For those patients who report having had constipation, will ask them to rate the severity of their constipation on a monthly basis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: Equipment malfunction.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toileting in Adults With Impaired Functional StatusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Cullen, Stanford University
- Investigators
- Yusra Hussain, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042157
- Sponsor's protocol ID
- IRB-22588
- Status last verified
- Oct 2017
- First submitted
- 17 Jan 2014
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
- ClinicalTrials.gov ID
- NCT02042157
- Acronym / sponsor ID
- IRB-22588
- 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
- Keywords
- Quality of Life, Caregivers, Caregiver burden, Urinary Tract Infections, Bidet, Women's health, Toileting, Hygiene
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Equipment malfunction.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our expectations (hypotheses) are:
Primary outcome
- 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).
- Regular bidet use by adults with impaired functional status will improve the quality of life around toileting for their caregivers. Secondary
- Regular bidet use will reduce the incidence, frequency and severity of constipation (as measured by self-report) in adults with impaired functional status.
- Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult women with impaired functional status.
Detailed description
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.
Functional 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.
Urinary 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.
Constipation 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bidet use | Experimental | Behavioral: Bidet useThis 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. |
| Usual Toileting | Placebo comparator | Other: Regular toiletingThis group will toilet as usual. |
| Caregivers of PT in Arm 1 (bidet use) | Experimental | Behavioral: Bidet useParticipants 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. |
| Caregivers of PT in Arm 2 (usual toileting) | Placebo comparator | Other: Regular toiletingParticipants 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. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 55-95 Sex: Female Ethic background: Reflecting the population at Stanford Hospital and Clinics who meet the inclusion criteria and who agree to participate.
- Sample 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.
Key exclusion criteria (8 listed)
- Participants not meeting the inclusion criteria.
- Life expectancy less than 2 years
- The inability to read and write English.
- Patients with indwelling urinary (e.g. Foley) catheters
- Use of any water based cleaning system after toileting at home in the past 12 months (bidet, water pot, douche etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bidet useParticipants 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. | Behavioural | Bidet use, Caregivers of PT in Arm 1 (bidet use) |
| Regular toiletingPatients in the control arm will toilet as usual. | Other | Caregivers of PT in Arm 2 (usual toileting), Usual Toileting |
Primary outcome
Improved quality of life as measured QoL questionnaire
Time frame: 24 months
We are measuring the quality of life using a validated QoL questionnaire which has been slightly modified to include questions around toileting.
Caregiver burden for caregivers of adults with functional limitations as measured by a validated caregiver burden questionnaire.
Time frame: 24 months
We will measure caregiver burden using a validated instrument.
3 secondary outcomes
Incidence of UTI as measured by enquiry and chart review (female patients only).
Time frame: 24 months
Incidence of constipation as measured by self report
Time frame: 24 months
Severity (measured by self report) of constipation
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Equipment malfunction.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Search engines for all clinical research taking place at Stanford Medical CenterLink provided by the sponsor.
- Portal for Stanford Aging Adult ServicesLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusra Hussain, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bidet use and Regular toileting in people with Toileting in Adults With Impaired Functional Status and Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Equipment malfunction.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved quality of life as measured QoL questionnaire (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.