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

Indwelling Urinary Catheter Users Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04243902
• Other study ID #: 41448
• Secondary ID: 245818
• Status: Withdrawn
• Phase: N/A
• Start date: February 13, 2022
• Est. completion date: July 18, 2023

Study information

• Verified date: October 2023
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Indwelling Urinary Catheter Users

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton	Southampton	Hampshire

Sponsors (4)

Lead Sponsor	Collaborator
University of Southampton	BlueWind Medical, National Institute for Health Research, United Kingdom, University Hospital Southampton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety: Effectiveness	Bladder emptying - proportion of valve voids with residual urine <100ml - as measured by bladder scanner.	An average of 16 hours in total
Primary	Safety: Effectiveness	Bladder emptying - Participant report (Valve self-report questionnaire)	An average of 16 hours in total
Primary	Comfort	Participant report (Valve self-report questionnaire)	An average of 16 hours in total
Secondary	User acceptability	Valve self-report questionnaire (Valve self-report questionnaire)	An average of 16 hours in total
Secondary	User acceptability	EQ-5D-5L	An average of 16 hours in total
Secondary	User acceptability	Long-term Catheter Quality of Life Tool	An average of 16 hours in total