NCT04243902

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The fill and flush valve (valve) 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.

Detailed description

The objective of this study is to assess preliminary safety, effectiveness, reliability, comfort and user acceptability of the valve with adults who have a long-term IDC and the feasibility of undertaking future community-based evaluation. To do this the investigators will * determine if the valve functions reliably i.e. automatically opens to drain urine within acceptable individual bladder volumes with a range of patients; * determine if the valve functions effectively i.e. allows for the complete bladder emptying (\< 100ml post void residual) during rest and daily activities; * determine if the process of filling and automatic draining is comfortable and acceptable for participants; * collect preliminary data on the potential for bioburden/biofilm following in human use of the valve; * assess the feasibility of undertaking a future randomised control trial of the valve. Group 1 - The investigators will test the valve with participants (n=8) who currently use a standard manual valve (without leg-bag).This first group will include a safety cohort of participants (n=4). All safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation. Group 2- The Investigators will test the valve with participants (n=8) who currently use a drainage bag with free drainage. The data collection process and study procedures will be identical for both groups. After use(in both groups), the valves will be examined microbiologically in the University of Southampton laboratory to detect bioburden and/or biofilm to ascertain a baseline for future studies.

Conditions

• Indwelling Urinary Catheter Users

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-13
• Primary completion: 2023-07-18
• Completion: 2023-07-18
• First posted: 2020-01-28
• Last updated: 2023-10-06

Locations

1 site across 1 country: United Kingdom