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.
Highlights
One participant was ineligible for crossover to balloon dilation due to an improvement in Eustachian tube dysfunction (ETD) symptoms (ETDQ-7 score
The mean (SD) change in overall ETDQ-7 score is –2.9 (1.4) for balloon dilation compared with –0.6 (1.0) for control: the decrease in ETDQ-7 score is significantly greater for the group undergoing balloon dilation compared with the control group ( p < 0.0001), demonstrating that balloon dilation is superior to the control
The results demonstrate that improvement in ETDQ-7 scores was significantly better ( p < 0.01 in all cases) for participants undergoing balloon dilation compared with participants in the control group, whether or not the participants had normal or abnormal tympanic membrane position, Valsalva maneuver, or tympanogram type at baseline
Summary
Study Design and Population This was a prospective, multicenter, randomized controlled trial comparing balloon dilation to continued medical therapy (control) in patients with persistent ETD. Participants 18 years and older were eligible for enrollment if they were diagnosed with ETD for 12 months or longer with 3 or more ETD symptoms (ear pain, ear pressure, tinnitus, cracking or popping in ears, muffled hearing, feeling that ears are clogged) and were refractory to medical therapy. Failed medical therapy was defined as a minimum of either 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 12 months before study enrollment. Participants were required to have an overall Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score of 3 or higher, representing moderate to severe symptoms [13]. All participants were required to have a computed tomography scan of the temporal bones and participants with evidence of carotid artery dehiscence were not eligible for the study
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