Back to resultsEvaluation Trial of Handheld Urinal for Adult Use
Primary Purpose
Urinary Incontinence
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
RS - WP06
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Suffers from nocturia urge, frequency, or funnctional incontinence
Exclusion Criteria:
- Suffers only from stress UI
Sites / Locations
- Binding Sciences Limited
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Adult nocturia
Adult urge urinary incontinence
Adult frequency urinary incontinence
Adult functional incontinence
Arm Description
Use of device over 28 days
Use of device over 28 days
Use of device over 28 days
Use of device over 28 days
Outcomes
Primary Outcome Measures
Changes in fluid intake
Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device.
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04897932
First Posted
April 16, 2021
Last Updated
May 18, 2021
Sponsor
Binding Sciences Limited
Collaborators
Buckinghamshire Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04897932
Brief Title
Evaluation Trial of Handheld Urinal for Adult Use
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2021 (Anticipated)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Binding Sciences Limited
Collaborators
Buckinghamshire Healthcare NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adult nocturia
Arm Type
Active Comparator
Arm Description
Use of device over 28 days
Arm Title
Adult urge urinary incontinence
Arm Type
Active Comparator
Arm Description
Use of device over 28 days
Arm Title
Adult frequency urinary incontinence
Arm Type
Active Comparator
Arm Description
Use of device over 28 days
Arm Title
Adult functional incontinence
Arm Type
Active Comparator
Arm Description
Use of device over 28 days
Intervention Type
Device
Intervention Name(s)
RS - WP06
Intervention Description
Ad hoc use of handheld urinal
Primary Outcome Measure Information:
Title
Changes in fluid intake
Description
Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device.
Time Frame
28 days
Title
Change in incidence of falls associated with urinary toileting
Description
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
Time Frame
28 days (3 months reported number of falls based on participant's recollection of incidence during that period)
Title
Change in level of user independence
Description
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
Time Frame
28 days
Title
Levels of user confidence
Description
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
Time Frame
28 days
Title
Convenience in use
Description
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
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Suffers from nocturia urge, frequency, or funnctional incontinence
Exclusion Criteria:
Suffers only from stress UI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keith A Binding, MBA
Phone
+441295 408029
Email
keith@bindingsciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Odling, MEng
Phone
+441295 408029
Email
melissa@bindingsciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piers Clifford, MD
Organizational Affiliation
Buckinghamshire Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Binding Sciences Limited
City
Cropredy
State/Province
Oxfordshire
ZIP/Postal Code
OX17 1PX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation Trial of Handheld Urinal for Adult Use
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