First-in-human testing of the Flume urinary catheter
Research type
Research Study
Full title
A new urinary catheter designed to improve bladder drainage: first-in-human testing of the FLUME catheter. Version 1.0
IRAS ID
261189
Contact name
Marcus Drake
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
1 years, 6 months, 28 days
Research summary
The study is a first-in-human study of the “Flume” bladder catheter. The Flume catheter is a new type of indwelling catheter (a catheter that is left in place continuously) and is designed to prevent many of the risks associated with the current long-term indwelling catheters available on the market. The design of the Flume catheter aims to reduce irritation of the bladder, reduce infection rates and improve bladder drainage. Initial laboratory tests of the Flume catheter have demonstrated better drainage and resistance against infection compared to the most frequently used catheter, the Foley catheter (data in-house). The Flume catheter also offers the benefit that placement, retention and connections use the same approaches as the Foley design, so will be familiar to users and health care professionals.
The study will consist of three (3) sequential stages for established and new catheter users, who fulfil the eligibility criteria. The study is a progressive study and a steering committee (SSC) will confirm that there are no concerns relating to patient safety, recruitment rate nor the conduct of the protocol, prior to progression to the next stage of the trial the study
Stage 1 will undertake first-in-human testing to evaluate the short-term use and safety of the new Flume Catheter in 10 patients in a hospital setting.
Stage 2 will evaluate 15 long term catheter users using a Flume catheter instead of a Foley catheter for one month at their usual residence (“home”), with regular follow up.
Stage 3 will monitor the Flume Catheter in 40 patients in their usual residence for up to 3 months.
Evaluations will be made by using the long-term catheter QoL (ICIQ-LTCQqol), Patient Global Impression of Improvement (PGI-I), Visual Analogue Scale (VAS), and EuroQol EQ-5D. Qualitative data will also be collected. Safety will be assessed by appropriate recording and reporting of adverse events throughout the study. A stop-go decision will be taken after completion of each stage.
REC name
HSC REC A
REC reference
21/NI/0150
Date of REC Opinion
8 Nov 2021
REC opinion
Further Information Favourable Opinion