Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

February 13, 2022

Primary Completion Date

July 18, 2023

Study Completion Date

July 18, 2023

Conditions
Indwelling Urinary Catheter Users
Interventions
DEVICE

Fill and Flush Valve

"The fill and flush valve (Figure 1) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.~There are three variants of the valve which respond to different degrees of bladder pressure. People's bladders function at different pressure levels. One of the aims of this study is to gain preliminary data on which valve variant works and under which circumstances. Pressure ranges are as follows:~Low: 22 - 49cm H2O Medium: 35 - 61cm H2O High: 53 - 79cm H2O"

Trial Locations (1)

SO16 6RL

University Hospital Southampton, Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

collaborator

BlueWind Medical

INDUSTRY

collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

lead

University of Southampton

OTHER

NCT04243902 - Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial | Biotech Hunter | Biotech Hunter