Condition category
Ear, Nose and Throat
Date applied
07/09/2005
Date assigned
29/09/2005
Last edited
18/07/2011
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 Richard Coppin

ORCID ID

Contact details

Overton Surgery
Station Road
Overton
RG25 3DZ
United Kingdom
+44 (0)1256 770600
overtonsurgery@dial.pipex.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Bulb syringe study

Study hypothesis

Ear wax is a commonly presenting problem in primary care. It is surprisingly under-researched and as background to this study we have previously undertaken two pilot studies - a questionnaire study and a feasibility study.
Ear wax is commonly treated by syringing the ear and syringing has been shown to improve hearing and symptoms. However, most GPs have increasingly delegated managing ear wax to practice nurses. The annual salary costs of practice nurses undertaking ear syringing in UK general practice have been estimated at about £8 million. Could that time be better spent? Achieving current NHS targets (such as the New GP Contract) has significant workload implications. Patients do not like delays associated with treating ear wax and patients, GPs and practice nurses would like to encourage such self-help. In some countries plastic bulb syringes with which to irrigate the ear are widely available. Such devices could potentially be marketed in the UK. Their availability in the UK and evidence of their effectiveness and safety could both reduce demands on health service resources and satisfy patients' demands for rapid relief of symptoms. Preliminary results of the pilot study suggest bulb syringes are effective, safe and acceptable to patients.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Ear wax

Intervention

Self-treatment using a bulb syringe compared with the standard treatment of syringing by a practice nurse or GP.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Objective clearance of wax
2. Relief of symptoms
3. Acceptability of treatment
4. Unwanted effects of treatment
5. Proportion of people requiring further intervention within 6 weeks
6. Costs of prescriptions for subsequent ear care in 6 weeks from randomisation

Secondary outcome measures

Rates of consultation with GP and practice nurse for ear care at one and two years.

Overall trial start date

01/02/2004

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Adults presenting at participating surgeries with symptoms of ear wax and having wax occluding one or both ear drums.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

236

Participant exclusion criteria

History of perforated ear drum, other significant ear disease or surgery, signs of perforation or infection in the affected ear, patients with cognitive impairment sufficient to preclude them from following the instructions or completing the questionnaire.

Recruitment start date

01/02/2004

Recruitment end date

31/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Overton Surgery
Overton
RG25 3DZ
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Research Support Office
Building 37
Room 4033
University of Southampton
Southampton
SO17 1BJ
United Kingdom

Sponsor type

University/education

Website

http://www.soton.ac.uk

Funders

Funder type

University/education

Funder name

Royal College of General Practitioners Scientific Foundation Board, SFB/2003/32 (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. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18186996
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21403136

Publication citations

  1. Results

    Coppin R, Wicke D, Little P, Managing earwax in primary care: efficacy of self-treatment using a bulb syringe., Br J Gen Pract, 2008, 58, 546, 44-49, doi: 10.3399/bjgp08X263811.

  2. Results

    Coppin R, Wicke D, Little P, Randomized trial of bulb syringes for earwax: impact on health service utilization., Ann Fam Med, 9, 2, 110-114, doi: 10.1370/afm.1229.

Additional files

Editorial Notes