Evaluation Trial of Handheld Urinal for Adult Use

Not Applicable

• Conditions: Urinary Incontinence
• Interventions: Device: RS - WP06

• Registration Number: NCT04897932
• Lead Sponsor: Binding Sciences Limited

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.

Study Timeline

• Study First Submitted: 2021-04-16
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-24
• Last Update Posted: 2021-05-24
• Study Start: 2021-05-30
• Primary Completion: 2021-07-31
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Suffers from nocturia urge, frequency, or funnctional incontinence

Exclusion Criteria

• Suffers only from stress UI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult functional incontinence	RS - WP06	Use of device over 28 days
Adult urge urinary incontinence	RS - WP06	Use of device over 28 days
Adult nocturia	RS - WP06	Use of device over 28 days
Adult frequency urinary incontinence	RS - WP06	Use of device over 28 days

Primary Outcome Measures

Name	Time	Method
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.
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
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
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
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

Trial Locations

Locations (1)

Binding Sciences Limited; 🇬🇧 Cropredy, Oxfordshire, United Kingdom