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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?

SUBMITTER: Meyer TA 

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

REPOSITORIES: biostudies-literature

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

Meyer Ted A TA   O'Malley Ellen M EM   Schlosser Rodney J RJ   Soler Zachary M ZM   Cai Jason J   Hoy Mark J MJ   Slater Patrick W PW   Cutler Jeffrey L JL   Simpson Roger J RJ   Clark Michael J MJ   Rizk Habib G HG   McRackan Theodore R TR   D'Esposito Christopher F CF   Nguyen Shaun A SA  

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20180801 7


<h4>Objective</h4>Compare Eustachian tube balloon dilation versus continued medical therapy (control) for treating persistent Eustachian tube dysfunction (ETD).<h4>Study design</h4>Prospective, multicenter, randomized controlled trial.<h4>Setting</h4>Tertiary care academic center and private practice.<h4>Patients</h4>Diagnosed with medically refractory persistent ETD.<h4>Interventions</h4>1:1 Randomization to balloon dilation or control. After 6 weeks, control participants had the option to unde  ...[more]

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