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| Name | Class |
|---|---|
| Buckinghamshire Healthcare NHS Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult nocturia | Active Comparator | Use of device over 28 days |
|
| Adult urge urinary incontinence | Active Comparator | Use of device over 28 days |
|
| Adult frequency urinary incontinence | Active Comparator | Use of device over 28 days |
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| Adult functional incontinence | Active Comparator | Use of device over 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RS - WP06 | Device | Ad hoc use of handheld urinal |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keith A Binding, MBA | Contact | +441295 408029 | keith@bindingsciences.com | |
| Melissa Odling, MEng | Contact | +441295 408029 | melissa@bindingsciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Piers Clifford, MD | Buckinghamshire Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Binding Sciences Limited | Cropredy | Oxfordshire | OX17 1PX | United Kingdom |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |