Urinary Incontinence
Conditions
Brief summary
Usability and efficacy evaluation of a prototype handheld urinal for adult use
Detailed description
28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.
Interventions
DEVICERS - WP06
Ad hoc use of handheld urinal
Sponsors
Buckinghamshire Healthcare NHS Trust
Binding Sciences Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Suffers from nocturia urge, frequency, or funnctional incontinence
Exclusion criteria
* Suffers only from stress UI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fluid intake | 28 days | Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device. |
| Change in incidence of falls associated with urinary toileting | 28 days (3 months reported number of falls based on participant's recollection of incidence during that period) | Quantitative analysis of the number of falls incurred going to and from toilet while using the device over the 28 day study period compared to the number of falls recalled by participants going to and from the toilet during the 3 months prior to the study when not using the device. Tool: user diary and questionairre |
| Change in level of user independence | 28 days | Quantitative assessment of number of carer interventions required to assist users with urinary toileting when using and not using the device. Tool: user diary and questionairre |
| Levels of user confidence | 28 days | Qualitative self-assessments, on a three-point scale of Not at all confident, Reasonably confident and Very confident, by users of their confidence in their ability to manage urinary incontinence when using the device in a range of different orientations. Tool: questionairre |
| Convenience in use | 28 days | Qualitative self-assessment by users of the convenience in use of the device relative to other continence aids used on a three-point scale: More convenient, Neither more nor less convenient, and Less convenient. Tool: questionairre |
Countries
United Kingdom
Contacts
Primary ContactKeith A Binding, MBA
Backup ContactMelissa Odling, MEng
Outcome results
None listed