Urinary IncontinenceNCT04897932
Evaluation Trial of Handheld Urinal for Adult Use
A study testing RS - WP06 in people with Urinary Incontinence, run by Binding Sciences Limited at 1 site in United Kingdom.
Trial summary
Usability and efficacy evaluation of a prototype handheld urinal for adult use Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- RS - WP06
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Suffers from nocturia urge, frequency, or funnctional incontinence
Who cannot join
- Suffers only from stress UI
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Binding Sciences Limited
Cropredy, Oxfordshire, OX17 1PX
About this study
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
Usability and efficacy evaluation of a prototype handheld urinal for adult use
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- RS - WP06
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS - WP06Device
Ad hoc use of handheld urinal
| Study group | Role | What they receive |
|---|---|---|
| Adult nocturia | Active comparator | Use of device over 28 days Receives: Device: RS - WP06 |
| Adult urge urinary incontinence | Active comparator | Use of device over 28 days Receives: Device: RS - WP06 |
| Adult frequency urinary incontinence | Active comparator | Use of device over 28 days Receives: Device: RS - WP06 |
| Adult functional incontinence | Active comparator | Use of device over 28 days Receives: Device: RS - WP06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fluid intake
Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start30 May 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binding Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Buckinghamshire Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Piers Clifford, MD, Principal investigator, Buckinghamshire Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897932
- Sponsor's protocol ID
- BSL BHT IRAS 291714
- Status last verified
- May 2021
- First submitted
- 16 Apr 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04897932
- Acronym / sponsor ID
- BSL BHT IRAS 291714
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Binding Sciences LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Buckinghamshire Healthcare NHS Trust
- Study start
- 30 May 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult nocturia | Active comparator | Device: RS - WP06Use of device over 28 days |
| Adult urge urinary incontinence | Active comparator | Device: RS - WP06Use of device over 28 days |
| Adult frequency urinary incontinence | Active comparator | Device: RS - WP06Use of device over 28 days |
| Adult functional incontinence | Active comparator | Device: RS - WP06Use of device over 28 days |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Suffers from nocturia urge, frequency, or funnctional incontinence
Key exclusion criteria (1 listed)
- Suffers only from stress UI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS - WP06Ad hoc use of handheld urinal | Device | Adult frequency urinary incontinence, Adult functional incontinence, Adult nocturia, Adult urge urinary incontinence |
Primary outcome
Changes in fluid intake
Time frame: 28 days
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
Time frame: 28 days (3 months reported number of falls based on participant's recollection of incidence during that period)
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
Time frame: 28 days
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
Time frame: 28 days
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
Time frame: 28 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piers Clifford, MD principal investigator
Buckinghamshire Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RS - WP06 in people with Urinary Incontinence, run by Binding Sciences Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith A Binding, MBA (+441295 408029, keith@bindingsciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fluid intake (time frame: 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.