Evaluation Trial of Handheld Urinal for Adult Use

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: RS - WP06

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keith A Binding, MBA; Phone Number: +441295 408029; Email: keith@bindingsciences.com
• Study Contact Backup: Name: Melissa Odling, MEng; Phone Number: +441295 408029; Email: melissa@bindingsciences.com

Study Locations

• United Kingdom
  • Oxfordshire
    • Cropredy, Oxfordshire, United Kingdom, OX17 1PX
      • Binding Sciences Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Suffers from nocturia urge, frequency, or funnctional incontinence

Exclusion Criteria:

• Suffers only from stress UI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adult nocturia; Use of device over 28 days	Device: RS - WP06; Ad hoc use of handheld urinal
Active Comparator: Adult urge urinary incontinence; Use of device over 28 days	Device: RS - WP06; Ad hoc use of handheld urinal
Active Comparator: Adult frequency urinary incontinence; Use of device over 28 days	Device: RS - WP06; Ad hoc use of handheld urinal
Active Comparator: Adult functional incontinence; Use of device over 28 days	Device: RS - WP06; Ad hoc use of handheld urinal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Binding Sciences Limited
• Collaborators: Buckinghamshire Healthcare NHS Trust
• Investigators: Principal Investigator: Piers Clifford, MD, Buckinghamshire Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2021
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: BSL BHT IRAS 291714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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