Feasibility Study of Balloon Eustachian Tuboplasty (BET)

Feasibility Study of Balloon Eustachian Tuboplasty (BET) for Grade 2 and 3 Pars Tensa Retractions

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)).

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:

• Craniofacial abnormalities (assessed by history and examination)
• Cholesteatoma (assessed by history, otoscopy, tympanogram, PTA)
• Nasopharyngeal tumours (assessed by flexible nasendoscopy)
• Adenoid hypertrophy (assessed by flexible nasendoscopy)
• Patulous ET (assessed by history, otoscopy and tympanogram)
• Previous middle ear surgery (assessed by history and otoscopy)
• Concurrent use of anticoagulant medication