Evaluation Trial of Handheld Urinal for Adult Use

Study Overview
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Brief Summary
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Usability and efficacy evaluation of a prototype handheld urinal for adult use

Detailed Description
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28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.

Official Title
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An Evaluation of the Usability and Efficacy of a Prototype Handheld Urinal for Adults Who Suffer From Nocturia, Urge, Frequency, and/or Functional Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: RS - WP06


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suffers from nocturia urge, frequency, or funnctional incontinence Exclusion Criteria: Suffers only from stress UI

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adult nocturia<br>Use of device over 28 days | Device: RS - WP06<br>* Ad hoc use of handheld urinal<br>|
| Active Comparator: Adult urge urinary incontinence<br>Use of device over 28 days | Device: RS - WP06<br>* Ad hoc use of handheld urinal<br>|
| Active Comparator: Adult frequency urinary incontinence<br>Use of device over 28 days | Device: RS - WP06<br>* Ad hoc use of handheld urinal<br>|
| Active Comparator: Adult functional incontinence<br>Use of device over 28 days | Device: RS - WP06<br>* Ad hoc use of handheld urinal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fluid intake | Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device. | 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 | 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 | 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 | 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 | 28 days |