The FLUME catheter study
Research type
Research Study
Full title
A Pragmatic Study to Illustrate and Compare the FLUME Catheter’s Drainage Performance and Patient Experience with the Foley Catheter in Suprapubic Patients.
IRAS ID
353996
Contact name
Nicholas Boxall
Contact email
Sponsor organisation
The Flume Catheter Company Ltd
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
This is primarily an imaging study that uses MRI scans to show what the Foley and FLUME catheters look like in the same bladder sequentially. We want to determine if there is an association between catheter discomfort and the type of catheter. Furthermore, we want to see if both types of catheter drain urine effectively and if one type has a larger residual urine than the other.
Background
The FLUME catheter is designed to address the significant limitations of traditional indwelling urinary catheters, such as pain, blockage, leakage, and infection. The catheter is distinguished by the configuration of the retention balloon, that envelops the catheter tip on inflation with the drainage holes deliberately inset low down, designed to aid drainage. The catheter has FDA 510(k) clearance for both urethral and suprapubic placements. First placements at Southmead Hospital, Bristol have confirmed the basic function of the FLUME catheter, i.e its ability to be placed, drain urine for the bladder and be removed, in just the same manner as a Foley catheter. Early evaluations have also indicated potential benefits, including reduced discomfort and bladder spasms. A COMFORT study is planned to gather the experiences of 40 long term catheter patients, comparing the relative comfort of their existing Foley catheter with the FLUME catheter. The primary function of an indwelling urinary catheter is bladder drainage and this study aims to further assess this aspect of the performance of the FLUME catheter, specifically the 16Fr device with 10ml fill, in comparison to traditional Foley catheters.
REC name
HSC REC B
REC reference
25/NI/0058
Date of REC Opinion
10 Jun 2025
REC opinion
Further Information Favourable Opinion