Usability and efficacy evaluation of a prototype handheld urinal for adult use
28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Ad hoc use of handheld urinal
Binding Sciences Limited
Cropredy, Oxfordshire, United Kingdom
Changes in fluid intake
Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device.
Time frame: 28 days
Change in incidence of falls associated with urinary toileting
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
Time frame: 28 days (3 months reported number of falls based on participant's recollection of incidence during that period)
Change in level of user independence
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
Time frame: 28 days
Levels of user confidence
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
Time frame: 28 days
Convenience in use
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
Time frame: 28 days
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