Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction

The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.

Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.

Study Overview

• Status: Completed
• Conditions: Chronic Eustachian Tube Dysfunction; Chronic Recurrent Otitis Media; Effusion After Tympanostomy
• Intervention / Treatment: Device: Eustachian tube dilatation device; Procedure: Myringotomy

Detailed Description

The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group.

Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. The otomicro(endo)scopy, symptoms severity according to VAS (Visual Analogue Pain Scale), ETDQ-7 (Eustachian Tube Dysfunction Questionnaire) questionnaire, tympanometry, audiometry and the possibility of Valsalva and Toynbee maneuver will be used to evaluate the effect of balloon ET dilatation. Only patients with standard treatment failure will be included in the study. Tuboplasty with and without myringotomy will be performed (and compared) in patients with chronic otitis media with effusion. Subgroups will be compared in order to find patients who could profit from the treatments the most.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Hradec Králové Region
    • Hradec Králové, Hradec Králové Region, Czechia, 500 05
      • University Hospital Hradec Kralove
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 708 52
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy

Exclusion Criteria:

• anatomic obstruction in nasopharynx
• nasopharyngeal cancer
• head and neck cancer
• other middle ear surgery except for myringotomy or tympanostomy
• chronic suppurative otitis media
• patients who could not undergo general anesthesia
• patients who did not give consent to be included in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Effusion, Eustachian tube dilatation device and myringotomy; Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty, and myringotomy	Device: Eustachian tube dilatation device; Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.; Procedure: Myringotomy; Myringotomy will be performed using a standard procedure.
Experimental: Effusion, Eustachian tube dilatation device; Patients with chronic Eustachian tube dysfunction and recurrence of chronic otitis media with effusion after tympanostomy tube exclusion, intervention: balloon Eustachian tuboplasty only (no myringotomy)	Device: Eustachian tube dilatation device; Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.
Experimental: No effusion, Eustachian tube dilatation device; Patients with chronic Eustachian tube dysfunction and airy middle ear (without otitis media with effusion), Eustachian tube dilatation device, no myringotomy	Device: Eustachian tube dilatation device; Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Otomicro(endo)scopy	Otomicro(endo)scopy will be used to assess the presence or absence of effusion.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms severity according to Visual Analogue Scale	Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.	36 months
ETDQ-7 questionnaire	The patients will be asked to fill-in the Eustachian Tube Dysfunction Questionnaire in order to assess the symptoms of Eustachian Tube Dysfunction (ETD). The ETDQ-7 is a valid and reliable symptom score for use in adult patients with ETD. The ETDQ-7 tool consists of seven items with a scale of graduated responses ranging from 1 to 7, with "1" corresponding to the absence of the suggested symptom and "7", to maximum symptom severity.	36 months
Tympanometry	Type of tympanometry curve (A, B, C) according to Joerger et al.	36 months
Audiometry	Hearing loss according to WHO classification (mild, moderate, severe).	36 months
Tubomanometry	Assessment of opening pressure in Eustachian tube in mmHg.	36 months
Possibility of Valsalva and Toynbee manoeuvre	The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no)	36 months

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: University Hospital Hradec Kralove
• Investigators: Study Chair: Pavel Komínek, prof.,MD,Ph.D.,MBA, University Hospital Ostrava; Principal Investigator: Martin Formánek, MD, University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: otitis media with effusion; Eustachian tube; Eustachian tube dysfunction; balloon tuboplasty
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: FNO-ENT-BET; MH CZ - DRO - FNOs/2016 (Other Grant/Funding Number: Ministry of Health of the Czech Republic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The investigators have not decided to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No