Condition category
Urological and Genital Diseases
Date applied
27/11/2009
Date assigned
27/01/2010
Last edited
04/07/2011
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 Ade Apoola

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RD-5103-012-07

Study information

Scientific title

How painful is a urethral swab? A single centre, randomised controlled trial.

Acronym

Study hypothesis

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

Derbyshire Research Ethics Committee (REC) approved on the 3rd of March 2008 (ref: 07/H0401/158)

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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)

Secondary outcome measures

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.

Overall trial start date

19/05/2008

Overall trial end date

19/11/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

121

Participant 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

Recruitment start date

19/05/2008

Recruitment end date

19/11/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Derby Hospitals NHS Foundation Trust (UK)

Sponsor details

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340131
teresa.grieve@derbyhospitals.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.derbyhospitals.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Derby Hospitals NHS Foundation 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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21131307

Publication citations

  1. Results

    Apoola A, Herrero-Diaz M, FitzHugh E, Rajakumar R, Fakis A, Oakden J, A randomised controlled trial to assess pain with urethral swabs., Sex Transm Infect, 2011, 87, 2, 110-113, doi: 10.1136/sti.2010.042861.

Additional files

Editorial Notes