NCT04897932

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

April 16, 2021

Last Update Submit

May 18, 2021

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (4)

Adult nocturia

ACTIVE COMPARATOR

Use of device over 28 days

Device: RS - WP06

Adult urge urinary incontinence

ACTIVE COMPARATOR

Use of device over 28 days

Device: RS - WP06

Adult frequency urinary incontinence

ACTIVE COMPARATOR

Use of device over 28 days

Device: RS - WP06

Adult functional incontinence

ACTIVE COMPARATOR

Use of device over 28 days

Device: RS - WP06

Interventions

RS - WP06DEVICE

Ad hoc use of handheld urinal

Adult frequency urinary incontinenceAdult functional incontinenceAdult nocturiaAdult urge urinary incontinence

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Suffers from nocturia urge, frequency, or funnctional incontinence

You may not qualify if:

  • Suffers only from stress UI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binding Sciences Limited

Cropredy, Oxfordshire, OX17 1PX, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Piers Clifford, MD

    Buckinghamshire Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith A Binding, MBA

CONTACT

+441295 408029keith@bindingsciences.com

Melissa Odling, MEng

CONTACT

+441295 408029melissa@bindingsciences.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

May 24, 2021

Study Start

May 30, 2021

Primary Completion

July 31, 2021

Study Completion

September 30, 2021

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)