Contact information
Type
Scientific
Primary contact
Prof David Neal
ORCID ID
Contact details
Cancer Research UK Cambridge Research Institute
Li Ka Shing Centre
Robinson Way
Cambridge
CB2 0RE
United Kingdom
+44 (0)1223 404 179
david.neal@cancer.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC045R r/2453/7000
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
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 names
Trimethoprim and ciprofloxacin
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/01/1999
Overall trial end date
05/01/2002
Reason abandoned
Eligibility
Participant inclusion criteria
The sample groups are drawn from adult patients who are attending the Freeman Hospital for flexible cystoscopy or urodynamics.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
11/01/1999
Recruitment end date
05/01/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK Cambridge Research Institute
Cambridge
CB2 0RE
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17822463
Publication citations
-
Results
Johnson MI, Merrilees D, Robson WA, Lennon T, Masters J, Orr KE, Matthews JN, Neal DE, Oral ciprofloxacin or trimethoprim reduces bacteriuria after flexible cystoscopy., BJU Int., 2007, 100, 4, 826-829, doi: 10.1111/j.1464-410X.2007.07093.x.