Ignite Creation Date:
2024-05-06 @ 2:26 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02042157
Status:
TERMINATED
Last Update Posted:
2017-10-19
First Post:
2014-01-17
Brief Title:
Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Equipment malfunction
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None