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.

FIG. 1

Participant flow diagram through 12-month follow-up.

FIG. 2

Primary efficacy endpoint: change in mean overall ETDQ-7 scores at 6 weeks by randomized treatment arm. P value is based on a one-sided, two-sample Student's t test comparing change from baseline between randomized arms with p < 0.025 indicating statistical significance. The change from baseline (Δ) is presented as the mean ± standard deviation. ETDQ-7 indicates 7-item Eustachian Tube Dysfunction Questionnaire.

FIG. 3

Mean overall ETDQ-7 scores over time for all participants undergoing Eustachian tube balloon dilation (randomized or crossover). P values are based on the mixed effects model of repeated measures (MMRM) analysis for the comparison between baseline and each follow-up visit. Error bars indicate standard deviations. ETDQ-7 scores of 1 to 2 indicate no to mild symptoms, 3 to 5 indicate moderate symptoms, and 6 to 7 indicate severe symptoms. ETDQ-7 indicates 7-item Eustachian Tube Dysfunction Questionnaire.