Development and first-in-human testing of FLUME urinary catheter with protected tip and relocated drainage holes
Development and first-in-human testing of FLUME urinary catheter with protected tip and relocated drainage holes
Purpose: evaluation of a catheter design which protects its tip with the retaining balloon when inflated, and has eyeholes at the base of the balloon to improve drainage.
Materials and methods: preclinical tests included assessment of retaining balloon performance, and microbiological blockage. Clinical testing evaluated short-term use and safety in hospital (stage 1) or the patient’s usual residence (stage 2).
Results: the retaining balloon supported static loads of 0.7kg, with reduced trauma when modelling forced evulsion. In vitro time to blockage with P. Mirabilis was significantly slower for FLUME compared with latex Foley catheters, but not the silicone Foley. Stage 1 testing (10 patients) confirmed balloon inflation, drainage, retention and removal, with no serious adverse events caused by catheterisation; one balloon failed to inflate, one patient could not be catheterised. Of five patients at stage 2, one had the catheter for 28 days without complication, one experienced spontaneous balloon deflation (14th day) and three needed early removal (blood clot, bypassing, difficulty connecting the drainage bag). Bacterial profiles of two FLUME catheters retained at least 2 weeks matched the Foley catheters. Acquired catheter colouration (two FLUME, one Foley) was not associated with biochemical change in the material.
Conclusion: FLUME catheter performed well in preclinical blockage and balloon tests. Tests in 15 patients confirmed basic function and additional training was not needed for staff familiar with Foley catheterisation. Clinical issues commonly seen with catheters included failed catheterisation, clot blockage and bypassing. In addition, an unintended balloon deflation and a failure of bag connection occurred.
Plain language summary: this article describes a new catheter design which aims to improve patient comfort and safety, and maximise bladder drainage, by protecting the bladder from the exposed catheter tip and by locating the drainage holes better. Various tests were done to check the catheter retaining balloon was safe and how well the catheter did when exposed to bacteria that could block it. The catheter was also used in people for the first time, to check it could be put in safely and functioned as intended. The results showed the FLUME catheter did well in the balloon and blockage tests. Tests in 15 patients confirmed basic function and showed placement was easy for staff familiar with conventional catheters. There were some clinical issues typical of urinary catheters and some possible improvements were identified.
Catheter, Catheter associated urinary tract infection, First in human, Foley catheter, Microbiology
Drake, Marcus J.
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Anderson, Katherine
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Gammie, Andrew
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Morris, Nicola
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Timlin, Tony
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Cotterill, Nikki
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Duff, John
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Fader, Mandy
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Taylor, Hazel
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Holmes, Roger
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Havard, John
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December 2023
Drake, Marcus J.
60d630c3-0d89-4513-94b6-72671bd28b94
Anderson, Katherine
e20ccbf3-14a9-43a6-b5fc-d69a22ebddf8
Gammie, Andrew
cfd28641-b0df-475b-8bf5-af742d3a98c5
Morris, Nicola
21c7fb9f-b3fb-4073-bc31-90c83ada3856
Timlin, Tony
860643ce-f244-4311-85c5-872255baf01b
Cotterill, Nikki
c0ef5dfc-a9ae-4ebb-a3ed-5afb7805ff92
Duff, John
40a6aa7f-68bd-4f3f-887f-29761a9af0e7
Fader, Mandy
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Taylor, Hazel
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Holmes, Roger
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Havard, John
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Drake, Marcus J., Anderson, Katherine, Gammie, Andrew, Morris, Nicola, Timlin, Tony, Cotterill, Nikki, Duff, John, Fader, Mandy, Taylor, Hazel, Holmes, Roger and Havard, John
(2023)
Development and first-in-human testing of FLUME urinary catheter with protected tip and relocated drainage holes.
Continence, 8, [101054].
(doi:10.1016/j.cont.2023.101054).
Abstract
Purpose: evaluation of a catheter design which protects its tip with the retaining balloon when inflated, and has eyeholes at the base of the balloon to improve drainage.
Materials and methods: preclinical tests included assessment of retaining balloon performance, and microbiological blockage. Clinical testing evaluated short-term use and safety in hospital (stage 1) or the patient’s usual residence (stage 2).
Results: the retaining balloon supported static loads of 0.7kg, with reduced trauma when modelling forced evulsion. In vitro time to blockage with P. Mirabilis was significantly slower for FLUME compared with latex Foley catheters, but not the silicone Foley. Stage 1 testing (10 patients) confirmed balloon inflation, drainage, retention and removal, with no serious adverse events caused by catheterisation; one balloon failed to inflate, one patient could not be catheterised. Of five patients at stage 2, one had the catheter for 28 days without complication, one experienced spontaneous balloon deflation (14th day) and three needed early removal (blood clot, bypassing, difficulty connecting the drainage bag). Bacterial profiles of two FLUME catheters retained at least 2 weeks matched the Foley catheters. Acquired catheter colouration (two FLUME, one Foley) was not associated with biochemical change in the material.
Conclusion: FLUME catheter performed well in preclinical blockage and balloon tests. Tests in 15 patients confirmed basic function and additional training was not needed for staff familiar with Foley catheterisation. Clinical issues commonly seen with catheters included failed catheterisation, clot blockage and bypassing. In addition, an unintended balloon deflation and a failure of bag connection occurred.
Plain language summary: this article describes a new catheter design which aims to improve patient comfort and safety, and maximise bladder drainage, by protecting the bladder from the exposed catheter tip and by locating the drainage holes better. Various tests were done to check the catheter retaining balloon was safe and how well the catheter did when exposed to bacteria that could block it. The catheter was also used in people for the first time, to check it could be put in safely and functioned as intended. The results showed the FLUME catheter did well in the balloon and blockage tests. Tests in 15 patients confirmed basic function and showed placement was easy for staff familiar with conventional catheters. There were some clinical issues typical of urinary catheters and some possible improvements were identified.
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e-pub ahead of print date: 8 November 2023
Published date: December 2023
Additional Information:
Funding Information:
This work was supported by the Elizabeth Blackwell Institute for Health Research, University of Bristol and Medical Research Council, United Kingdom . This report is independent research funded by the National Institute for Health Research, United Kingdom (Research for Patient Benefit, A new urinary catheter to improve bladder drainage: first-in-human testing of the Flume catheter, PB-PG-0317-20026 ). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care . The clinical research was sponsored by North Bristol NHS Trust, United Kingdom . We thank the study steering committee, Alan Cottenden (chair), Chris Foy and Sheilagh Reid. We also thank the Public and Patient Advisory Group; Jack Duff (Chair), Amanda Threlfall, Rashmi Kumar and Susan Billing.
Funding Information:
This work was supported by the Elizabeth Blackwell Institute for Health Research, University of Bristol and Medical Research Council, United Kingdom. This report is independent research funded by the National Institute for Health Research, United Kingdom (Research for Patient Benefit, A new urinary catheter to improve bladder drainage: first-in-human testing of the Flume catheter, PB-PG-0317-20026). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The clinical research was sponsored by North Bristol NHS Trust, United Kingdom. We thank the study steering committee, Alan Cottenden (chair), Chris Foy and Sheilagh Reid. We also thank the Public and Patient Advisory Group; Jack Duff (Chair), Amanda Threlfall, Rashmi Kumar and Susan Billing.
Publisher Copyright:
© 2023 The Authors
Keywords:
Catheter, Catheter associated urinary tract infection, First in human, Foley catheter, Microbiology
Identifiers
Local EPrints ID: 485839
URI: http://eprints.soton.ac.uk/id/eprint/485839
ISSN: 2772-9737
PURE UUID: f16df8d9-6554-47bc-86a1-2e5db5cf69c3
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Date deposited: 20 Dec 2023 17:35
Last modified: 17 Mar 2024 06:32
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Contributors
Author:
Marcus J. Drake
Author:
Katherine Anderson
Author:
Andrew Gammie
Author:
Nicola Morris
Author:
Tony Timlin
Author:
Nikki Cotterill
Author:
John Duff
Author:
Hazel Taylor
Author:
Roger Holmes
Author:
John Havard
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