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

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.

Study Overview

• Status: Withdrawn
• Conditions: Indwelling Urinary Catheter Users
• Intervention / Treatment: Device: Fill and Flush Valve

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6RL
      • University Hospital Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• IDC-users (urethral or suprapubic), over 18, who have had a catheter in situ for at least one month and use a manual valve or drainage bag to collect urine
• Independent with catheter care needs (e.g. bag emptying or valve opening)
• Able to transfer from bed to chair, stand and walk short distances unaided
• Able to drink moderate levels of fluid (500mls in the first 2 hours and 150mls per hour thereafter)
• Able to provide informed consent (self-report and research nurse assessment)
• Usual medical provider provides confirmation of suitability

Exclusion Criteria:

• End stages of a terminal illness
• Current treatment of urinary tract infection
• Has been advised by a urologist against using a valve on clinical grounds
• Lack of bladder sensation (e.g. unable to sense when bladder needs emptying)
• Previous bladder surgery that could affect the integrity of the bladder
• At known risk of autonomic dysreflexia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 - standard manual valve (without leg-bag); The valve will initially be tested in 8 participants 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.	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; Other Names: EM02, EM03, EM04
Experimental: 2 - drainage bag with free drainage; The valve will then be tested with participants (n=8) who currently use a drainage bag with free drainage.	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; Other Names: EM02, EM03, EM04

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Reliability	Valve opening - Proportion of observations of automatic valve opening before bladder capacity (500ml or less) is reached - as measured by bladder scanner	An average of 16 hours in total
Safety: Effectiveness	Bladder emptying - proportion of valve voids with residual urine <100ml - as measured by bladder scanner.	An average of 16 hours in total
Safety: Effectiveness	Bladder emptying - Participant report (Valve self-report questionnaire)	An average of 16 hours in total
Comfort	Participant report (Valve self-report questionnaire)	An average of 16 hours in total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User acceptability	Valve self-report questionnaire (Valve self-report questionnaire)	An average of 16 hours in total
User acceptability	EQ-5D-5L	An average of 16 hours in total
User acceptability	Long-term Catheter Quality of Life Tool	An average of 16 hours in total

Collaborators and Investigators

• Sponsor: University of Southampton
• Collaborators: BlueWind Medical; University Hospital Southampton NHS Foundation Trust; National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Cathy Murphy, University of Southampton

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2022
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: IDC; urinary catheter
• Other Study ID Numbers: 41448; 245818 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No