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Inability to recruit any trial partcipants
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This is a study that aims to evaluate the feasibility of undertaking a United Kingdom (UK) multi-centre randomised controlled trial of BET for the treatment of moderate (grade 2 or 3) retraction pockets (RPs). This future study will aim to address the question: Does BET improve symptoms scores, audiometry and otoscopic appearance of Grade 2-3 pars tensa RPs in adult patients?
Currently conservative treatments for this condition has been shown to be ineffective; there is a significant risk of progression to hearing loss or more serious complications in untreated retraction pockets; and the surgical treatments available to us in the UK not only have a number of risks and drawbacks, but also do not aim to treat the underlying cause (Eustachian Tube dysfunction (ETD)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Eustachian Tuboplasty | Experimental | Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bielefeld balloon | Device | Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Acceptability of the procedure, which will be assessed with pre- and post-procedure using the the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7). | 6 months |
| Patient Focus Group | Thematic analysis of Patient Focus Group discussions. Standardised questions and focus group discussion with patients with (i) un-operated asymptomatic Retraction Pockets (RPs), (ii) un-operated symptomatic RPs, (iii) RPs treated with cartilage tympanoplasty, and (iv) RPs treated with BET. These will qualitatively assess (as appropriate) positive and negative aspects of patient experience, such as living with the RP, the procedure itself, their recovery, any after effects, and participating in the study. Focus groups will consist of 6 patients in each group. | 6 months |
| Complications | An assessment of the number of complications in the 20 participants undergoing BET will also be performed as a marker of safety of the procedure. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Demand | Demand assessed by recruitment rate | 1 year |
| Cost analysis of treatment | Cost analysis of BET vs. cartilage tympanoplasty | 1 year |
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Inclusion Criteria:
Adult patients over 18 years old with grade 2-3 retraction pocket of the tympanic membrane as assessed by study clinician.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Rainsbury, BMBS MSc FRCS | University Hospital Plymouth NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plymouth Hospitals NHS Trust | Plymouth | Devon | PL6 8DH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40008607 | Derived | Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2. |
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| Comparison of otoendoscopy images | Comparison of otoendoscopy images by two experienced observers and computer software (ImageJ). Assessed pre-intervention and post-intervention at 2 weeks and 6 months. | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. |
| Ability to perform Valsalva | Ability to perform Valsalva measured as always, sometimes or never. Assessed pre-intervention and post-intervention at 2 weeks and 6. | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. |
| Tympanometry | Tympanometry (peak middle ear pressure and compliance, and Jerger grade (Improved, unchanged, worse)). Assessed pre-intervention and post-intervention at 2 weeks and 6 months. | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. |
| pure-tone average (PTA) hearing loss | PTA (air conduction at 0.25, 0.5, 1, 2, 3, 4, 6, 8kHz; bone conduction at 0.5, 1, 2, 3, 4 kHz) with calculation of air bone gap at 0.5, 1, 2, 3 and 4kHz. Assessed pre-intervention and post-intervention at 2 weeks and 6 months | Assessed pre-intervention and post-intervention at 2 weeks and 6 months. |