Antibiotic Prophylaxis for Clean Intermittent Catheterisation

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.

Conditions

• Urinary Tract Infections, Recurrent

Interventions

DRUG

Nitrofurantoin or Trimethoprim or Cefalexin

Antibiotic prophylaxis

OTHER

No prophylaxis

Discrete treatment courses of antibiotics as indicated by symptoms or signs of UTI.

Sponsors & Collaborators

• NHS Health Technology Assessment Programme

  collaborator OTHER

• Newcastle University

  collaborator OTHER

• Glasgow Caledonian University

  collaborator OTHER

• University of Aberdeen

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• North Bristol NHS Trust

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Robert Pickard, MD · Newcastle University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2017-02-22

Completion

2017-02-22

Countries

• United Kingdom

Study Locations