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

Not Applicable

Terminated

• Conditions: UTI in Adults With Impaired Functional Status; Caregiver Burden for Those Who Care for Adults With Impaired Functional Status; Toileting in Adults With Impaired Functional Status
• Interventions: Behavioral: Bidet use; Other: Regular toileting

• Registration Number: NCT02042157
• Lead Sponsor: Stanford University

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).

Study Timeline

• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-22
• Study Start: 2015-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bidet use	Bidet use	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.
Usual Toileting	Regular toileting	This group will toilet as usual.
Caregivers of PT in Arm 1 (bidet use)	Bidet use	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.
Caregivers of PT in Arm 2 (usual toileting)	Regular toileting	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.

Primary Outcome Measures

Name	Time	Method
Improved quality of life as measured QoL questionnaire	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.	24 months	We will measure caregiver burden using a validated instrument.

Secondary Outcome Measures

Name	Time	Method
Incidence of UTI as measured by enquiry and chart review (female patients only).	24 months	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.
Incidence of constipation as measured by self report	24 months	We will ask patients on a monthly basis if they have had constipation.
Severity (measured by self report) of constipation	24 months	For those patients who report having had constipation, will ask them to rate the severity of their constipation on a monthly basis.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States