An Evaluation of the Usability and Efficacy of a Prototype Handheld Urinal for Adults Who Suffer From Nocturia, Urge, Frequency, and/or Functional Incontinence
Sponsor study identifier
interventional
100
1 country
1
Study Start
May 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Usability and efficacy evaluation of a prototype handheld urinal for adult use
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 16, 2021
Actual (reported)May 24, 2021
Actual (reported)May 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Use of device over 28 days
Use of device over 28 days
Use of device over 28 days
Ad hoc use of handheld urinal
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Binding Sciences Limited
Cropredy, Oxfordshire, OX17 1PX, United Kingdom
Piers Clifford, MD
Buckinghamshire Healthcare NHS Trust
First Submitted
April 16, 2021
First Posted
May 24, 2021
Study Start
May 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 31, 2021
Estimated (date passed)ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes
Use of device over 28 days
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 24, 2021
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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