A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up

Abstract

Objective:Compare Eustachian tube balloon dilation versus continued medical therapy (control) for treating persistent Eustachian tube dysfunction (ETD).Study Design:Prospective, multicenter, randomized controlled trial.Setting:Tertiary care academic center and private practice.Patients:Diagnosed with medically refractory persistent ETD.Interventions:1:1 Randomization to balloon dilation or control. After 6 weeks, control participants had the option to undergo balloon dilation if symptoms persisted.Main Outcome Measures:Primary efficacy endpoint was the comparison between treatment arms in the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Primary safety endpoint was complication rate.Results:Sixty participants were randomized (31 balloon dilation, 29 control). Mean (SD) change in overall ETDQ-7 score at 6 weeks was −2.9 (1.4) for balloon dilation compared with −0.6 (1.0) for control: balloon dilation was superior to control (p < 0.0001). No complications were reported in either study arm. Among participants with abnormal baseline assessments, improvements in tympanogram type (p < 0.006) and tympanic membrane position (p < 0.001) were significantly better for balloon dilation than control. Technical success was 100% (91 successful dilations/91 attempts) and most procedures (72%) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation.Conclusions:Balloon dilation is a safe and effective treatment for persistent ETD. Based on improved ETDQ-7 scores, balloon dilation is superior to continued medical management for persistent ETD. Symptom improvement is durable through a minimum of 12 months. Procedures are well tolerated in the office setting under local anesthesia.

The prevalence of eustachian tube dysfunction symptoms in temporomandibular joint disorder patients

“…As the use of the ETDQ‐7 becomes more common in clinical practice and research, it has been used, perhaps mistakenly, as a stand‐in for an objective diagnostic test for ETD . Prominent studies on ETD, including the recent randomized control trial of the XprESS ENT Dilation System (Entellus Medical, Plymouth, MN), included the ETDQ‐7 as a primary diagnostic test and clinical endpoint for device efficacy . The patient population of the XprESS study included only those patients with ETDQ‐7 score of ≥21 (≥3 average per question) at baseline and therefore deemed to have severe ETD.…”

“…2 Prominent studies on ETD, including the recent randomized control trial of the XprESS ENT Dilation System (Entellus Medical, Plymouth, MN), included the ETDQ-7 as a primary diagnostic test and clinical endpoint for device efficacy. 17 The patient population of the XprESS study included only those patients with ETDQ-7 score of ≥21 (≥3 average per question) at baseline and therefore deemed to have severe ETD. However, 71% of patients had normal tympanograms at baseline.…”

Sekretorische Otitis media – Kombination von Tuboplastie und Paukendrainage

“…[3,4]. Grundsätzlich wurden ebenfalls der Begriff der "Tubenfunktionsstörung" und seine Beurteilungskriterien präziser definiert, um eine Vergleichbarkeit der Studien zu erzielen [5].…”

“…Grundsätzlich muss jedoch darauf hingewiesen werden, dass ein Paukenerguss zwar Ausdruck einer Tubenfunktionsstörung sein kann, jedoch nicht mit dieser gleichzusetzen ist [5]. Insgesamt handelt es sich bei der Ballondilatation der Tube um ein sich entwickelndes Verfahren, bei dem zurzeit noch keine langjährigen Erfahrungen vorliegen.…”

“…Leider ist auch die Verwendung des Begriffs "Chronic recurrent secretory otitis media (CRSOM)" nicht genau mit dem Begriff "therapieresistenter Paukenerguss" gleichzusetzen. Die von den Autoren benutzte Nomenklatur zeigt deutlich die eingeschränkte Vergleichbarkeit zwischen bisher vorliegenden Untersuchungen und stellt die Problematik unpräziser Definitionen heraus [2,5]. Dies unterstreicht die Notwendigkeit weiterer größerer kontrollierter randomisierter Studien.…”