Evaluation Trial of Handheld Urinal for Adult Use

NCT ID: NCT04897932

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-30

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adult nocturia

Use of device over 28 days

Group Type ACTIVE_COMPARATOR

RS - WP06

Intervention Type DEVICE

Ad hoc use of handheld urinal

Adult urge urinary incontinence

Use of device over 28 days

Group Type ACTIVE_COMPARATOR

RS - WP06

Intervention Type DEVICE

Ad hoc use of handheld urinal

Adult frequency urinary incontinence

Use of device over 28 days

Group Type ACTIVE_COMPARATOR

RS - WP06

Intervention Type DEVICE

Ad hoc use of handheld urinal

Adult functional incontinence

Use of device over 28 days

Group Type ACTIVE_COMPARATOR

RS - WP06

Intervention Type DEVICE

Ad hoc use of handheld urinal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RS - WP06

Ad hoc use of handheld urinal

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Suffers from nocturia urge, frequency, or funnctional incontinence

Exclusion Criteria

* Suffers only from stress UI
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Buckinghamshire Healthcare NHS Trust

OTHER

Sponsor Role collaborator

Binding Sciences Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Piers Clifford, MD

Role: PRINCIPAL_INVESTIGATOR

Buckinghamshire Healthcare NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Binding Sciences Limited

Cropredy, Oxfordshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Keith A Binding, MBA

Role: CONTACT

+441295 408029

Melissa Odling, MEng

Role: CONTACT

+441295 408029

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BSL BHT IRAS 291714

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.