Can antibiotic prophylaxis reduce the rate of infection secondary to flexible cystoscopy and urodynamics?
| ISRCTN | ISRCTN37802560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37802560 |
| Secondary identifying numbers | RRCC045R r/2453/7000 |
- 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
Scientific
Cancer Research UK Cambridge Research Institute
Li Ka Shing Centre
Robinson Way
Cambridge
CB2 0RE
United Kingdom
| Phone | +44 (0)1223 404 179 |
|---|---|
| david.neal@cancer.org.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Trimethoprim and ciprofloxacin |
| Primary outcome measure | 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 study start date | 11/01/1999 |
| Completion date | 05/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Cancer Research UK Cambridge Research Institute
Cambridge
CB2 0RE
United Kingdom
CB2 0RE
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
