Usability and efficacy trial of a prototype handheld urinal for adults
Research type
Research Study
Full title
An evaluation of the safety, usability and efficacy of a prototype handheld urinal for adults, in particular those with impaired physical mobility, manual dexterity and/or vision, who suffer from nocturia, urge, frequency, and/or functional incontinence.
IRAS ID
291714
Contact name
Keith Binding
Contact email
Sponsor organisation
Binding Sciences Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 12 days
Research summary
What health and wellbeing benefits does Releaf Seated, a novel handheld urinal, offer adult urinary incontinence sufferers with cognitive awareness and some degree of voluntary control, in particular those with impaired physical mobility and/or manual dexterity?
This study will evaluate the safety, usability and potential health and wellbeing benefits in community settings of a novel handheld urinal for adult male and female urinary incontinence (UI) sufferers who have cognitive awareness and voluntary control, particularly those with either impaired physical mobility or manual dexterity.
An estimated 5m UK citizens suffer urinary incontinence, resulting in an estimated £1.8+billion pa care burden to the NHS (The Urology Foundation). Age-related incontinence is expected to increase as the number of over 65s in the UK increases to an estimated 15.4m by 2030. Against this backdrop, NHS England (“Five Year Forward View”, 2014) emphasised the need to help “frail and older people stay healthy and independent, avoiding hospital stays where possible” and the role played by good continence management in achieving this (“Excellence in continence care”,2018). However, there is a poorly met need for non-worn UI aids that are convenient and easy to use for those with poor mobility or dexterity, particularly for females when seated.
The trial will evaluate the safety and usability of a prototype handheld urinal for use in seated and other orientations, and its potential health and wellbeing benefits for users and, where relevant, their carers. Participants will be provided with the device and a supply of consumables to be used, at home and elsewhere, over 28 days, with online and telephone support provided throughout. Participant feedback will be sought primarily by way of survey instrument, with clarification follow-up by telephone where necessary.
The trial is being undertaken by the Sponsor, Binding Sciences Limited, and Buckinghamshire Healthcare NHS Trust, with InnovateUK funding.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0159
Date of REC Opinion
5 Aug 2021
REC opinion
Further Information Favourable Opinion