NCT05626062

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

November 15, 2022

Last Update Submit

November 15, 2022

Conditions

Keywords

IncontinenceLearning disabilities

Outcome Measures

Primary Outcomes (2)

  • Number of instances of incontinence

    The intervention should promote less instances of incontinence

    12 weeks

  • Number of instances of successful voiding in a toilet

    The intervention should promote more instances of successful voiding in a toilet

    12 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

30 adults with learning disabilities with incontinence will be offered a 12-week personalised toilet training plan, which promotes prompted voiding in a toilet

Device: Toilet alarm

Interventions

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

Intervention group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adults with learning disabilities with incontince across all levels of learning disabilities (mild to profound)

You may not qualify if:

  • Cannot sit on a toilet for up to 3 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Glasgow Caledonian University

Glasgow, Lanarkshire, G4 0BA, United Kingdom

RECRUITING

Glasgow Caledonian University

Glasgow, Scotland, G4 0BA, United Kingdom

RECRUITING

Related Publications (1)

  • Finlayson J, Gore N, Ord P, Roche F, Butcher J, Kean R, Skelton DA. Urinary Tract Infections Amongst Adults With Intellectual Disabilities With Urinary Incontinence. J Appl Res Intellect Disabil. 2025 Jan;38(1):e13317. doi: 10.1111/jar.13317.

MeSH Terms

Conditions

Urinary IncontinenceLearning Disabilities

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A feasibility sample of 30 adults with learning disabilities with incontinence
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

August 28, 2022

Primary Completion

September 27, 2023

Study Completion

November 27, 2023

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations