Urinary IncontinenceNCT05626062
Toilet Training and Adults With Learning Disabilities
A study testing Toilet alarm in people with Urinary Incontinence, run by Glasgow Caledonian University at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Toilet alarm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Aug 2022to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with learning disabilities with incontince across all levels of learning disabilities (mild to profound)
Who cannot join
- Cannot sit on a toilet for up to 3 minutes
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Glasgow Caledonian University
Glasgow, Lanarkshire, G4 0BA
Janet Finlayson, PhD, 0141 331 3083, Janet.Finlayson@gcu.ac.uk
- Recruiting
Glasgow Caledonian University
Glasgow, Scotland, G4 0BA
Janet Finlayson, PHD, 0141 331 3083, Janet.Finlayson@gcu.ac.uk
About this study
Official title: Toileting Assessment and Toilet Training for Adults With Learning Disabilities With Incontinence
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.
Read the detailed 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.
- Conditions
- Urinary Incontinence
- Being tested
- Toilet alarm
- Keywords
- Incontinence, Learning disabilities
- Medical subject headings
- Urinary Incontinence, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toilet alarmDevice
A Malem toilet alarm (wristworn, discretely in underwear, or bed mat) will be used to promote prompred voiding in a toilet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Toilet alarm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of instances of incontinence
The intervention should promote less instances of incontinence
Measured: 12 weeks
Number of instances of successful voiding in a toilet
The intervention should promote more instances of successful voiding in a toilet
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start28 Aug 2022
- Primary completion27 Sep 2023 (estimated)
- Study completion27 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A feasibility sample of 30 adults with learning disabilities with incontinence
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626062
- Sponsor's protocol ID
- R4451
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39508283
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toileting Assessment and Toilet Training for Adults With Learning Disabilities With Incontinence
- ClinicalTrials.gov ID
- NCT05626062
- Acronym / sponsor ID
- R4451
- Conditions
- Urinary Incontinence
- Keywords
- Incontinence, Learning disabilities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- University of Kent
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 27 Sep 2023 (estimated)
- Study completion
- 27 Nov 2023 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A feasibility sample of 30 adults with learning disabilities with incontinence
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Toilet alarm30 adults with learning disabilities with incontinence will be offered a 12-week personalised toilet training plan, which promotes prompted voiding in a toilet |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with learning disabilities with incontince across all levels of learning disabilities (mild to profound)
Key exclusion criteria (1 listed)
- Cannot sit on a toilet for up to 3 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toilet alarmA Malem toilet alarm (wristworn, discretely in underwear, or bed mat) will be used to promote prompred voiding in a toilet | Device | Intervention group |
Primary outcome
Number of instances of incontinence
Time frame: 12 weeks
The intervention should promote less instances of incontinence
Number of instances of successful voiding in a toilet
Time frame: 12 weeks
The intervention should promote more instances of successful voiding in a toilet
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 39508283Finlayson 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.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toilet alarm in people with Urinary Incontinence, run by Glasgow Caledonian University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of instances of incontinence (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05626062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.