Antibiotic Prophylaxis for Clean Intermittent Catheterisation
Status:
Completed
Trial end date:
2017-02-22
Target enrollment:
Participant gender:
Summary
This research project is designed to find out whether people who suffer repeated urinary
tract infections (UTI) related to the need to empty their bladders intermittently with a fine
plastic tube (catheter); a process called clean intermittent self-catheterisation (CISC),
benefit from taking continuous daily low-dose antibiotics (antibiotic prophylaxis). The
investigators estimate that about 40,000 people in the United Kingdom need to use CISC
regularly to empty their bladder either because of nerve damage such as multiple sclerosis or
because of failure of the bladder muscle to contract, and of these about 25% (10,000 people)
suffer frequent UTI. One way to reduce this problem may be to take a small daily dose of
antibiotics and the study aims to find out whether such treatment is effective and worthwhile
both for the people who suffer the problem and for the National Health Service (NHS).
The two options to be compared in the trial are firstly, a once daily preventive dose
(prophylaxis) of an antibiotic routinely used for this purpose (either nitrofurantoin or
trimethoprim or cefalexin), and secondly no prophylaxis. The investigators think that an
overall decrease of 20% or more in the frequency of UTI would be large enough for future
patients using CISC who get troublesome recurrent UTIs to be offered antibiotic prophylaxis
routinely. The investigators will also assess any harm caused by continuous use of
antibiotics, particularly side effects for those people taking them and changes in the
resistance of bacteria to these antibiotics. The investigators can then work out whether the
balance between the benefits and harms make the use of prophylaxis worthwhile to people
carrying out CISC and for the NHS as a whole.
Phase:
Phase 4
Details
Lead Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators:
Cambridge University Hospitals NHS Foundation Trust Glasgow Caledonian University Newcastle University NHS Health Technology Assessment Programme North Bristol NHS Trust University of Aberdeen University of Southampton