How painful is a urethral swab?

ISRCTN	ISRCTN50938901
DOI	https://doi.org/10.1186/ISRCTN50938901
Protocol serial number	RD-5103-012-07
Sponsor	Derby Hospitals NHS Foundation Trust (UK)
Funder	Derby Hospitals NHS Foundation Trust (UK)

Submission date: 27/11/2009
Registration date: 27/01/2010
Last edited: 04/07/2011

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ade Apoola
Scientific

Derby Hospitals NHS Foundation Trust
London Road Community Hospital
Genito-Urinary Department
London Road
Derby
DE1 2QY
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	How painful is a urethral swab? A single centre, randomised controlled trial.
Study objectives	To investigate the intensity of the discomfort felt during the insertion of the first urethral swab, when different swab types are used. 1. To determine if there is any difference in the discomfort felt during the insertion of the first of three urethral swabs using different types. 2. To investigate the intensity of the discomfort felt during the insertion of the second and the third urethral swab using different types. 3. To determine if there is an association between particular healthcare workers (HCW) and the discomfort experienced during a urethral swab procedure. 4. To assess if previous experience of swab taking in the patient has an effect on the perception of discomfort felt during the procedure. 5. To assess if urethral inflammation affects the discomfort felt during the procedure.
Ethics approval(s)	Derbyshire Research Ethics Committee (REC) approved on the 3rd of March 2008 (ref: 07/H0401/158)
Health condition(s) or problem(s) studied	Genito-urinary medicine
Intervention	Following informed consent, participants will be randomised to receive one of the following types of swab first: 1. To have a gonorrhoea Dacron tipped swab first 2. To have a chlamydia Rayon tipped swab first 3. To have a plastic urethral loop swab first All patients will have the other 2 types of swab taken as routine practice in an order pre-specified by the pre-randomised envelopes. Participants will be given a short questionnaire to complete before the first swab is taken for investigations. Participants will be given a numerical rating scale to measure intensity of discomfort felt after each of the 3 swabs have been taken. All three swabs are routinely taken in clinics in accordance with manufacturers instructions. The duration of the study will be 6 months
Intervention type	Other
Primary outcome measure(s)	The discomfort felt during urethral swab procedure after the first of 3 different swab types are used, will be assessed using the Visual Analogue Scale (0-100mm)
Key secondary outcome measure(s)	1. The discomfort during the procedure using each of the other two types of swab using the Visual Analogue Scale (0-100mm) will be assessed. 2. Data on presence and severity of urethral symptoms prior to swab taking will be collected using the Data Collection form. 3. Data will also be collected on the identity of the HCW taking the swab and the presence of epithelial cells (a marker of an adequately taken swab) and polymorphonuclear cells (a marker of inflammation) in the specimen and voided urine after swabs.
Completion date	19/11/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	121
Key inclusion criteria	All male patients over 16 attending the Genito-Urinary clinic during the study period and having swab tests will be invited to participate in the study.
Key exclusion criteria	1. Subjects who have passed urine within 2 hours of planned procedure (swab) 2. Subjects who have taken analgesics, anti-depressants or anti-epileptic drugs in the previous 24 hours
Date of first enrolment	19/05/2008
Date of final enrolment	19/11/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Derby Hospitals NHS Foundation Trust

Derby
DE1 2QY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/03/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes