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

NCT ID: NCT04243902

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-13
• Study Completion Date: 2023-07-18

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fill and Flush Valve

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Fill and Flush Valve

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

EM02, EM03, EM04

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

BlueWind Medical

INDUSTRY

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cathy Murphy

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

University Hospital Southampton

Southampton, Hampshire, United Kingdom

Countries

United Kingdom

Other Identifiers

245818

Identifier Type: OTHER

Identifier Source: secondary_id

41448

Identifier Type: -

Identifier Source: org_study_id