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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
-
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.