Condition category
Urological and Genital Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
15/03/2016
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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

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