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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02042157
First received: January 17, 2014
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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 Intervention
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
Device: Bidet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Improved quality of life as measured QoL questionnaire [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    We will measure caregiver burden using a validated instrument.


Secondary Outcome Measures:
  • Incidence of UTI as measured by enquiry and chart review (female patients only). [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    We will ask patients on a monthly basis if they have had constipation.

  • Severity (measured by self report) of constipation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    For those patients who report having had constipation, will ask them to rate the severity of their constipation on a monthly basis.


Estimated Enrollment: 400
Study Start Date: June 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bidet
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.
Device: Bidet
A bidet is a device installed on the toilet that provides fresh water to help clean the bottom and genitalia after having a bowel movement or urinating.
Other Name: Royal Fresh Bidet (non-electric toilet attachment)
Placebo Comparator: Usual Toileting
This group will toilet as usual.
Experimental: Caregivers of PT in Arm 1 (bidet)
Participants with functional impairment will be randomized into one of two arms (bidet 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.
Device: Bidet
A bidet is a device installed on the toilet that provides fresh water to help clean the bottom and genitalia after having a bowel movement or urinating.
Other Name: Royal Fresh Bidet (non-electric toilet attachment)
Placebo Comparator: Caregivers of PT in Arm 2 (no bidet)
Participants with functional impairment will be randomized into one of two arms (bidet 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.

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

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042157

Contacts
Contact: Yusra N Hussain, MD 650-714-3343 ynhussen@stanford.edu
Contact: Isabella Chu, MPH 650-723-2513 isabella.chu@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Isabella Chu, MPH    650-723-2513    isabella.chu@stanford.edu   
Contact: Yusra Hussain, MD    650-714-3343    ynhussen@stanford.edu   
Principal Investigator: Merdad Ayati, MD         
Sub-Investigator: Yusra Hussain, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Mehrdad Ayati, MD Stanford University
Principal Investigator: Yusra Hussain, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02042157     History of Changes
Other Study ID Numbers: IRB-22588
Study First Received: January 17, 2014
Last Updated: June 10, 2014
Health Authority: United States: Stanford university administrative panel on human subjects in medical research

Keywords provided by Stanford University:
Women's health
Quality of Life
Caregivers
Caregiver burden
Urinary Tract Infections
Bidet
Toileting
Hygiene
Activities of Daily Living
Functional impairment
Geriatrics

ClinicalTrials.gov processed this record on July 28, 2014