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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05626062
Other study ID # R4451
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 28, 2022
Est. completion date November 27, 2023

Study information

Verified date November 2022
Source Glasgow Caledonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Incontinence is common in adults with learning disabilities (LDs). Behavioural toilet training in conjunction with toilet alarms is recommended for people with LDs, but there is a paucity of research, thus evidence-based practise, on behavioural toilet training for adults with LDs. The aim of this study is to assess the toileting needs and issues of 30 adults with LDs with incontinence, and determine whether a 12-week individualised positive behavioural support training intervention, with the use of toilet alarms, promotes continence.


Description:

Adults with learning disabilities with incontinence are being invited to participate in a 12-week personalised, positive toilet training plan, following assessment of their toileting needs. Primary outcome measures will be: number of incidences of incontinence, and number of instances of successful voiding in a toilet. Toilet alarms will be used to encourage prompted voiding in a toilet.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 27, 2023
Est. primary completion date September 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Adults with learning disabilities with incontince across all levels of learning disabilities (mild to profound) Exclusion Criteria: - Cannot sit on a toilet for up to 3 minutes

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Toilet alarm
A Malem toilet alarm (wristworn, discretely in underwear, or bed mat) will be used to promote prompred voiding in a toilet

Locations

Country Name City State
United Kingdom Glasgow Caledonian University Glasgow Lanarkshire
United Kingdom Glasgow Caledonian University Glasgow Scotland

Sponsors (2)

Lead Sponsor Collaborator
Glasgow Caledonian University University of Kent

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of instances of incontinence The intervention should promote less instances of incontinence 12 weeks
Primary Number of instances of successful voiding in a toilet The intervention should promote more instances of successful voiding in a toilet 12 weeks
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