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.

Resu

SUBMITTER: Meyer TA 

PROVIDER: S-EPMC6075883 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature