Urinary Tract Infections, Recurrent | Antibiotic Prophylaxis for Clean Intermittent Catheterisation
Urinary Tract Infections, Recurrent research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Adult men and women aged ≥ 18 years - Completed training of CISC and predicted to continue use for at least 12 months - Able to give informed consent for participation in trial - Able and willing to adhere to a 12‐month follow up period - Have either suffered at least two episodes of symptomatic UTI related to CISC within last 12 months. - or at least one episode of UTI requiring hospitalization, or for those previously prescribed prophylactic antibiotic for UTI, have completed a 3‐month washout period without antibiotic prophylaxis. - Able to take a once daily oral dose of at least one of nitrofurantoin, or trimethoprim, or cefalexin - Intermittent catheterisation may be performed by participant, spouse, or carer - No restriction on type of catheter used Exclusion Criteria: - Age < 18 years - In learning phase of CISC - Presence of symptomatic UTI - this will be treated and symptoms resolved prior to randomisation - Already taking prophylactic antibiotic against UTI and declining 3‐month washout period without antibiotic prophylaxis (this will be specifically monitored in the screening log) - Inability to take any of the three prophylactic antibiotic agents due to multiple drug sensitivities - Women who intend to become pregnant during planned period of trial participation or who are pregnant or who are breastfeeding - Previous participation in this study - Inability to give informed consent or have primary outcome information collected
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Urinary Tract Infections, Recurrent
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Nitrofurantoin or Trimethoprim or CefalexinAntibiotic prophylaxis
Other:No prophylaxisDiscrete treatment courses of antibiotics as indicated by symptoms or signs of UTI.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Antibiotic prophylaxisNitrofurantoin or Trimethoprim or Cefalexin. Daily antibiotic prophylaxis: nitrofurantoin 50 mg (or 100 mg dependent on participant weight), or trimethoprim 100 mg, or cefalexin 250 mg.
No prophylaxisThe control arm will be a strategy of no prophylaxis. Participants will self‐monitor their symptoms as usual and report to their General Practitioner if they develop symptoms and signs suggestive of UTI requiring treatment.
Start Date: September 2013
Completed Date: February 22, 2017
Phase: Phase 4
Primary Outcome: Relative incidence of symptomatic antibiotic‐treated UTI
Study sponsors, principal investigator, and references
Principal Investigator: Robert Pickard, MD
Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator: NHS Health Technology Assessment Programme