Contact information
Type
Scientific
Primary contact
Dr Conal S L Quah
ORCID ID
Contact details
115B Loftus House
Marton Road
Middlesbrough
TS4 3TQ
United Kingdom
+44 (0)7738005994
conalquah@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0227189911
Study information
Scientific title
Effect of prophylactic antibiotics on post flexible cystoscopy infection rate
Acronym
Study hypothesis
Are patients less susceptible to urinary tract infection post cystoscopy following administration of single-dose antibiotic prophylaxis?
Ethics approval
Newcastle and North Tyneside 1 Ethics Committee (UK), 06/03/2007, ref: REC 07/Q0905/3
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urological and Genital Diseases: Urinary tract infection (UTI)
Intervention
Null hypothesis: The use of a single dose oral antibiotic prophylaxis will not influence the rate of urinary tract infection post flexible cystoscopy.
Purpose: The aim of this study is to determine if patients are less susceptible to urinary tract infection post cystoscopy following administration of single-dose antibiotic prophylaxis.
Design: This study is a prospective randomised clinical trial. Every patient listed for flexible cystoscopy will be randomised appropriately, dividing them into 2 groups. One group will receive antibiotics and one group will not.
Methodology: Patients listed for flexible cystoscopy from Nov 06-March 07 will be recruited for this study. Clinicians and staff as well as the patients' GPs will be informed about this research study. Those recruited will be given a patient information sheet as well as informed consent obtained. Pre and post procedure urine samples will be obtained to objectively evaluate the presence of infection. Cystoscopies will be carried out in the surgical day unit (James Cook University Hospital) by either a specialist trainee or a consultant. External genitalia will be cleaned with topical chlorhexidine and plain lignocaine jelly 2% will be used for local anaesthetic. The cystoscope will be disinfected with Transept. 5-7 days post procedure, they would be required to return the urine samples to their respective GP. The results will be analyzed to determine the rate of positive cultures in both groups.
Predictable risks and inconvenience weighted against the anticipated benefits for participants include a small possibility of a side effect from the antibiotic. However, the antibiotic administration might prevent an infection post procedure hence the interest in this research study. The results of this study will then help develop a local protocol which will standardize the current practice. Patients may experience minor inconvenience as they have to hand in the urine sample themselves to the GP 5-7 days following the procedure.
Interpreting and analysing findings, preparing the final report will be done for around a month after the proposed recruitment date and a paper on the subject will be written and submitted to a national/international journal for peer review.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measure is to identify the incidence of urinary tract infection post flexible cystoscopy following prophylaxis antibiotic administration.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/11/2006
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female patients of all ages
2. Patients undergoing check or flexible cystoscopy
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
328, 80 patients recruited as of August 2008.
Participant exclusion criteria
1. High susceptibility patients who would have definitely received antibiotics - diabetics, immuno compromised patients, recurrent UTIs
2. Patients who underwent biopsy / procedure ie stent removal etc during cystoscopy
3. Patients with indwelling catheters
4. Patients who are allergic to Penicillin
Recruitment start date
15/11/2006
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
115B Loftus House
Middlesbrough
TS4 3TQ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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
South Tees Hospitals NHS Trust (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