Skip to content

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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02042157
Enrollment
28
Registered
2014-01-22
Start date
2015-01-01
Completion date
2016-12-31
Last updated
2017-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Burden for Those Who Care for Adults With Impaired Functional Status, Toileting in 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

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).

Interventions

BEHAVIORALBidet use

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.

OTHERRegular toileting

Patients in the control arm will toilet as usual.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Improved quality of life as measured QoL questionnaire24 monthsWe 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.24 monthsWe will measure caregiver burden using a validated instrument.

Secondary

MeasureTime frameDescription
Incidence of UTI as measured by enquiry and chart review (female patients only).24 monthsEvery 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.
Incidence of constipation as measured by self report24 monthsWe will ask patients on a monthly basis if they have had constipation.
Severity (measured by self report) of constipation24 monthsFor those patients who report having had constipation, will ask them to rate the severity of their constipation on a monthly basis.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026