NCT04243902

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

February 13, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

August 21, 2019

Last Update Submit

October 3, 2023

Conditions

Indwelling Urinary Catheter Users

Keywords

urinary catheterIDC

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • User acceptability

    An average of 16 hours in total

  • User acceptability

    An average of 16 hours in total

  • User acceptability

    An average of 16 hours in total

Study Arms (2)

1 - standard manual valve (without leg-bag)

EXPERIMENTAL

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

2 - drainage bag with free drainage

EXPERIMENTAL

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

Device: Fill and Flush Valve

Interventions

Fill and Flush ValveDEVICE

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

Also known as: EM02, EM03, EM04
1 - standard manual valve (without leg-bag)2 - drainage bag with free drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6RL, United Kingdom

Location

Study Officials

  • Cathy Murphy

    University of Southampton

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: 2 groups, 1 group including interim safety review
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

January 28, 2020

Study Start

February 13, 2022

Primary Completion

July 18, 2023

Study Completion

July 18, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)