Clinical trial NCT04243902: Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial
Official title: Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Indwelling Urinary Catheter Users
Keywords: urinary catheter
IDC
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: BlueWind Medical
name: University Hospital Southampton NHS Foundation Trust
First posted: 2020-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups, 1 group including interim safety review
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Safety: Reliability
timeFrame: An average of 16 hours in total
measure: Safety: Effectiveness
timeFrame: An average of 16 hours in total
measure: Safety: Effectiveness
timeFrame: An average of 16 hours in total
measure: Comfort
timeFrame: An average of 16 hours in total
Secondary outcomes:
measure: User acceptability
timeFrame: An average of 16 hours in total
measure: User acceptability
timeFrame: An average of 16 hours in total
measure: User acceptability
timeFrame: An average of 16 hours in total
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Cathy Murphy
role: PRINCIPAL_INVESTIGATOR
References: