Evaluation Trial of Handheld Urinal for Adult Use

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04897932
• Other study ID #: BSL BHT IRAS 291714
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2021
• Source: Binding Sciences Limited
• Contact: Keith A Binding, MBA
• Phone: +441295 408029
• Email: keith[@]bindingsciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Usability and efficacy evaluation of a prototype handheld urinal for adult use

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Suffers from nocturia urge, frequency, or funnctional incontinence

Exclusion Criteria:

• Suffers only from stress UI

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• RS - WP06
Ad hoc use of handheld urinal

Locations

Country	Name	City	State
United Kingdom	Binding Sciences Limited	Cropredy	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
Binding Sciences Limited	Buckinghamshire Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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