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

University of Southampton

Status: Withdrawn

Conditions: Indwelling Urinary Catheter Users

Treatments: Device: Fill and Flush Valve

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04243902

41448

245818 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1 - standard manual valve (without leg-bag)

Experimental group

Description:

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.

Treatment:

Device: Fill and Flush Valve

2 - drainage bag with free drainage

Experimental group

Description:

The valve will then be tested with participants (n=8) who currently use a drainage bag with free drainage.

Treatment:

Device: Fill and Flush Valve