Clinical trial NCT02042157: Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
Official title: Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Activities of Daily Living
Functional impairment
Geriatrics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-01-22
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Improved quality of life as measured QoL questionnaire
timeFrame: 24 months
measure: Caregiver burden for caregivers of adults with functional limitations as measured by a validated caregiver burden questionnaire.
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of UTI as measured by enquiry and chart review (female patients only).
timeFrame: 24 months
measure: Incidence of constipation as measured by self report
timeFrame: 24 months
measure: Severity (measured by self report) of constipation
timeFrame: 24 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yusra Hussain, MD
role: PRINCIPAL_INVESTIGATOR
References: