A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With...

Area of Science:

• Otolaryngology
• Medical Devices
• Clinical Trials

Background:

• Persistent Eustachian tube dysfunction (ETD) significantly impacts quality of life.
• Medical management is often insufficient for refractory ETD cases.
• Eustachian tube balloon dilation presents a minimally invasive treatment option.

Purpose of the Study:

• To compare the efficacy and safety of Eustachian tube balloon dilation against continued medical therapy for persistent ETD.
• To evaluate long-term symptom durability and procedural tolerability.

Main Methods:

• A prospective, multicenter, randomized controlled trial involving 60 participants with medically refractory persistent ETD.
• Participants were randomized 1:1 to receive either balloon dilation or continued medical therapy.
• The primary efficacy endpoint was the change in the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score at 6 weeks.

Main Results:

• Balloon dilation demonstrated superior improvement in ETDQ-7 scores compared to medical therapy (p < 0.0001).
• No complications were reported in either arm; procedures were technically successful (100%) and often performed under local anesthesia.
• Symptom improvements were maintained for at least 12 months post-dilation.

Conclusions:

• Eustachian tube balloon dilation is a safe, effective, and durable treatment for persistent ETD.
• Balloon dilation offers a significant advantage over continued medical management for improving ETD symptoms.
• The procedure is well-tolerated in an office setting, enhancing patient accessibility.