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

NCT04243902 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

  • Indwelling Urinary Catheter Users

Interventions

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

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • BlueWind Medical

    collaborator INDUSTRY

  • University Hospital Southampton NHS Foundation Trust

    collaborator OTHER

  • University of Southampton

    lead OTHER

Principal Investigators

  • Cathy Murphy · University of Southampton

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-13
Primary Completion
2023-07-18
Completion
2023-07-18

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04243902 on ClinicalTrials.gov