Protocol Summary

Short title: Antibiotic prophylaxis for clean intermittent catheterisation (The AnTIC Study)

Chief Investigator: Professor Robert Pickard

Sponsor: Newcastle upon Tyne Hospitals NHS Foundation Trust

Funder: NIHR HTA Programme

Study design: Pragmatic, superiority patient randomised controlled trial

Study Interventions: Experimental: Daily antibiotic prophylaxis for 12 months

Control: No antibiotic prophylaxis

Primary objective:

To determine whether antibiotic prophylaxis results in a clinically significant reduction in the rate of symptomatic, antibiotic-treated urinary tract infection suffered by people performing intermittent self-bladder catheterisation over 12 months and is cost-effective for the UK NHS.

Secondary objectives:

To determine whether use of antibiotic prophylaxis results in better quality of life, better satisfaction with treatment and has an acceptable safety profile including antibiotic stewardship.

Primary outcome: 

Relative incidence of symptomatic antibiotic-treated UTI between the trial groups over 12 months

Number of study sites: 40

Study population/size: 372

Study duration: 42 months (12 months active participation)