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

• ClinicalTrials.gov Identifier: NCT02042157
• Recruitment Status: Terminated
• First Posted: January 22, 2014
• Last Update Posted: October 19, 2017
• Sponsor: Stanford University
• Information provided by (Responsible Party): Mark Cullen, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Behavioral: Bidet use; Other: Regular toileting	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
• Study Start Date: January 1, 2015
• Actual Primary Completion Date: December 31, 2016
• Actual Study Completion Date: December 31, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Bidet 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.
Placebo Comparator: Usual Toileting; This group will toilet as usual.	Other: Regular toileting; Patients in the control arm will toilet as usual.
Experimental: Caregivers of PT in Arm 1 (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.	Behavioral: Bidet 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.
Placebo Comparator: Caregivers of PT in Arm 2 (usual 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.	Other: Regular toileting; Patients in the control arm will toilet as usual.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. Incidence of UTI as measured by enquiry and chart review (female patients only). [ Time Frame: 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.

2. Incidence of constipation as measured by self report [ Time Frame: 24 months ]
   We will ask patients on a monthly basis if they have had constipation.
3. Severity (measured by self report) of constipation [ Time Frame: 24 months ]
   For those patients who report having had constipation, will ask them to rate the severity of their constipation on a monthly basis.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Yusra Hussain, MD; Stanford University

More Information

Additional Information:

Search engines for all clinical research taking place at Stanford Medical Center  Portal for Stanford Aging Adult Services 

• Responsible Party: Mark Cullen, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT02042157
• Other Study ID Numbers: IRB-22588
• First Posted: January 22, 2014
• Last Update Posted: October 19, 2017
• Last Verified: October 2017

Keywords provided by Mark Cullen, Stanford University:

Bidet; Quality of Life; Caregivers; Caregiver burden; Urinary Tract Infections; Women's health; Toileting; Hygiene; Activities of Daily Living; Functional impairment; Geriatrics