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

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.