Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial

  • Poe D
  • Anand V
  • Dean M
 et al. 
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Abstract

Objectives/Hypothesis: To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in con-junction with medical management as treatment for Eustachian tube dilatory dysfunction. Study Design: In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. Methods: The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. Results: Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon cathe-ter 1 medical management compared to medical management alone. Tympanogram normalization at 6-week follow-up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P

Author-supplied keywords

  • Eustachian tube dysfunction
  • balloon catheter
  • normalization of tympanogram

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Authors

  • Dennis Poe

  • Vijay Anand

  • Marc Dean

  • William H. Roberts

  • Jose Pablo Stolovitzky

  • Karen Hoffmann

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