Condition category
Infections and Infestations
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes