RCT 1-Year Follow-up

A randomized controlled trial of balloon dilation as a treatment for persistent Eustachian tube dysfunction with 1-year follow-up.

Overview

This study compared balloon dilation with ongoing medical therapy for the treatment of persistent Eustachian tube dysfunction (ETD). Over 7.3 million people have symptoms of Eustachian tube dysfunction, including ear pain and pressure, ear fullness, muffled hearing, and pain or discomfort with barometric changes.3 Balloon dilation has recently emerged as a treatment option for ETD that has the potential to provide more durable relief than traditional alternatives.


Background

Study design

Prospective, multicenter, randomized controlled trial.

Setting

Tertiary care academic center and private practice.

Patient population

61 patients age 18 years and older, all previously diagnosed with medically refractory persistent ETD for 12 months or more, have failed medical therapy, and have moderate to severe symptoms as indicated by Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Participants were randomized 1:1 to balloon dilation or control.

Interventions

After 6 weeks, control participants had the option to undergo balloon dilation if symptoms persisted.

Outcomes measured

The primary efficacy endpoint was the comparison between treatment arms in the mean change from baseline in the overall ETDQ-7 score. The primary safety endpoint was complication rate.

Results

  • The 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 (p<0.0001).
ETBD comparison chart
  • ETDQ-7 scores are significantly reduced from 4.6 at baseline to 2.1 at 6 weeks post-dilation and remain stable through 12 months.
ETDQ Mean Overall chart
  • 72% of procedures were completed in office under local anesthesia.
  • Zero complications were reported.

 

 

Improvement chart

Conclusions

  • Balloon dilation with the XprESS® ENT dilation system is superior to continued medical management for improving symptoms (overall ETDQ-7 scores) in patients with persistent ETD.
  • Improvements in symptoms and middle ear assessments are durable through a minimum of 12 months.
  • Procedures are well tolerated under local anesthesia.
  • Balloon dilation with the XprESS device is a safe and effective treatment for patients with persistent ETD.

Featured publication

Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D’Esposito CF, Nguyen SA. A randomized controlled trial of balloon dilation as a treatment for persistent Eustachian tube dysfunction with 1-year follow-up. Otol Neurotol. 2018 Aug;39(7):894-902.

Browse clinical data:

Sinusitis

Eustachian tube dysfunction

Nasal airway obstruction