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 

Source: Otology and Neurotology - July 11, 2018 Category: ENT & OMF Tags: Prosthetic Devices Source Type: research