Can antibiotic prophylaxis reduce the rate of infection secondary to flexible cystoscopy and urodynamics?

ISRCTN	ISRCTN37802560
DOI	https://doi.org/10.1186/ISRCTN37802560
Protocol serial number	RRCC045R r/2453/7000
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 08/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Neal
Scientific

Cancer Research UK Cambridge Research Institute
Li Ka Shing Centre
Robinson Way
Cambridge
CB2 0RE
United Kingdom

Phone	+44 (0)1223 404 179
Email	david.neal@cancer.org.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Flexible cystoscopy and urodynamic investigations are both commonly performed urological procedures. Published evidence suggests that around 8% of patients have an Urinary Tract Infection (UTI) at the time of these procedures and 8% will develop infection following these procedures, subsequent to UTI patients may develop septicaemia. Patients may attend their General Practitioner with a UTI and never come to the attention of the department. Whether antibiotics given at the time of urodynamics or flexible cystoscopy reduce the incidence of infection is controversial, as most studies have had inadequate sample sizes. The largest trials show reduction in infection rate when antibiotic prophylaxis is used; however these studies used intramuscular antibiotics that are expensive and uncomfortable. The principal hypothesis addressed by this project is that oral antibiotic prophylaxis given as single dose significantly reduces the incidence of urinary tract infection following flexible cystoscopy and urodynamics. The project compares placebo with either oral ciprofloxacin or trimethoprim, in both flexible cystoscopy and urodynamics. The project will also examine whether antibiotic prophylaxis reduces the incidence of irritative voiding symptoms following flexible cystoscopy and urodynamics. To determine the cost of antibiotic prophylaxis in flexible cystoscopy and urodynamics.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Infection and infestations
Intervention	Comparison of a single dose of oral trimethoprim 200 mg or a single dose of ciprofloxacin 500 mg with placebo given to the patient one hour prior to the flexible cystoscopy or urodynamic study.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Trimethoprim and ciprofloxacin
Primary outcome measure(s)	1. Presence of symptomatic urinary tract infection following flexible cystoscopy or urodynamics as identified by a positive post-procedure Midstream Urine Specimen (MSU) and change in symptom score as identified using the American Urological Association (AUA) symptom bother score 2. Presence of asymptomatic bacteria following flexible cystoscopy or urodynamics as identified by a post-procedure MSU and lack of change in symptom score 3. Presence of irritative voiding symptoms following cystoscopy or urodynamics as identified by symptom score analysis in patients with a sterile MSU A UTI will be assumed to be present if there are more than 105 cfu/ml. A urine specimen will be obtained on admission for flexible cystocopy and at the time of the procedure for urodynamics. The patients will be discharged with a sterile container to allow a mid-stream urine specimen to be performed three days after the procedure. A simple symptom score analysis will be performed using the AUA symptom bother score questionnaire (Barry 1992). This will be filled in prior to the procedure and repeated three days after the procedure when the urine sample is returned. In addition a questionnaire detailing visits to the GP, the reason for the visit and the outcome of the visit will be completed. This questionnaire will be repeated at one month. In order to maximise the response rate, patients failing to return their questionnaires will be followed up with a telephone call requesting completion.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	05/01/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Key inclusion criteria	The sample groups are drawn from adult patients who are attending the Freeman Hospital for flexible cystoscopy or urodynamics.
Key exclusion criteria	1. Patients with heart valve replacements, cardiac murmurs, orthopaedic and vascular prostheses who require definitive antibiotic prophylaxis 2. Patients on antibiotics at the time of their investigation for other reasons 3. Patients with a urethral catheter in situ at the time of the investigation 4. Patients who are allergic to either trimethoprim or ciprofloxacin 5. Patients performing intermittent clean self catheterisation
Date of first enrolment	11/01/1999
Date of final enrolment	05/01/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cancer Research UK Cambridge Research Institute

Cambridge
CB2 0RE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2007		Yes	No