Infection and infestations Infections and Infestations Infection following cystoscopy or urodynamic investigation
Conditions
Interventions
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.
Sponsors
NHS R&D Regional Programme Register - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: The sample groups are drawn from adult patients who are attending the Freeman Hospital for flexible cystoscopy or urodynamics.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed