Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting

Stanford University

Status: Terminated

Conditions: Caregiver Burden for Those Who Care for Adults With Impaired Functional Status; UTI in Adults With Impaired Functional Status; Toileting in Adults With Impaired Functional Status

Treatments: Other: Regular toileting; Behavioral: Bidet use

Study type: Interventional

Funder types: Other

Identifiers

NCT02042157

IRB-22588

Details and patient eligibility

About

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. Regular bidet use by adults with impaired functional status will improve the quality of life around toileting for their caregivers.

   Secondary

3. Regular bidet use will reduce the incidence, frequency and severity of constipation (as measured by self-report) in adults with impaired functional status.

4. Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult women with impaired functional status.

Full 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).

Enrollment: 28 patients

Sex: All

Ages: 21 to 95 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

Participants not meeting the inclusion criteria.

Additional exclusion criteria:

1. Life expectancy less than 2 years
2. The inability to read and write English.
3. Patients with indwelling urinary (e.g. Foley) catheters
4. Use of any water based cleaning system after toileting at home in the past 12 months (bidet, water pot, douche etc).
5. Fully incontinent (eg diaper use)
6. Moderate to severe cognitive impairment (15 or lower on the MOCA)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups, including a placebo group

Bidet use

Experimental group

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.

Treatment:

Behavioral: Bidet use

Usual Toileting

Placebo Comparator group

Description:

This group will toilet as usual.

Treatment:

Other: Regular toileting

Caregivers of PT in Arm 1 (bidet use)

Experimental group

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.

Treatment:

Behavioral: Bidet use

Caregivers of PT in Arm 2 (usual toileting)

Placebo Comparator group

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.

Treatment:

Other: Regular toileting