Effect of prophylactic antibiotics on post flexible cystoscopy infection rate

ISRCTN	ISRCTN08814240
DOI	https://doi.org/10.1186/ISRCTN08814240
Secondary identifying numbers	N0227189911

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 15/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Conal S L Quah
Scientific

115B Loftus House
Marton Road
Middlesbrough
TS4 3TQ
United Kingdom

Phone	+44 (0)7738005994
Email	conalquah@yahoo.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effect of prophylactic antibiotics on post flexible cystoscopy infection rate
Study objectives	Are patients less susceptible to urinary tract infection post cystoscopy following administration of single-dose antibiotic prophylaxis?
Ethics approval(s)	Newcastle and North Tyneside 1 Ethics Committee (UK), 06/03/2007, ref: REC 07/Q0905/3
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/11/2006
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	328, 80 patients recruited as of August 2008.
Key inclusion criteria	1. Male and female patients of all ages 2. Patients undergoing check or flexible cystoscopy
Key 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
Date of first enrolment	15/11/2006
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

115B Loftus House

Middlesbrough
TS4 3TQ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

South Tees Hospitals NHS Trust (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

Editorial Notes

15/03/2016: No publications found, verifying study status with principal investigator.