Balloon eustachian tuboplasty in chronic suppurative otitis media and dilatory eustachian tube dysfunction: a randomized controlled trial.

Objectives: Balloon eustachian tuboplasty (BET) is an emerging treatment for dilatory eustachian tube (ET) dysfunction. However, its efficacy in patients with both chronic suppurative otitis media (COM) and ET dysfunction remains unclear. The objective of the trial was to assess the efficacy and safety of BET versus medical management (MM) alone in adult patients with COM and chronic dilatory ET dysfunction, which was defined by a failed Valsalva maneuver.

Methods: In this prospective, multicenter, randomized controlled trial, a total of 116 participants (121 ears) treated between January 2021 and June 2023 were randomly assigned (1:1) to receive either BET with MM or MM alone (fluticasone furoate nasal steroid spray). The short-term primary outcome was the normalization of the Valsalva maneuver at the 8-week follow-up. Secondary outcomes were improved Eustachian Tube Dysfunction Questionnaire- 7 (ETDQ-7) scores and decreased air-bone gap (ABG) analyzed at 8 weeks. Adverse events were monitored in both groups during the follow-up period.

Results: Among the 116 participants (121 ears), 60 participants (62 ears) received BET and 56 participants (59 ears) received MM alone. Demographics, baseline characteristics, ETDQ-7 scores, bone conduction thresholds, and ABG did not differ significantly between the groups. In the BET group, 46.8% (29/62, ears) achieved a successful Valsalva maneuver compared with 15.3% (9/59, ears) in the MM-only group (p<0.001). BET group (-6.2±9.4) showed greater subjective symptom improvement than the MM-only group (-2.6±8.6) regarding ETDQ-7 scores (p=0.028). ABG decreased more in the BET group (-5.8±11.4 dB) compared with the MM-only group (-1.2±10.5 dB) (p=0.023). No serious procedure-related or device-related adverse events occurred in either group during the 8-week follow-up.

Conclusion: Our trial suggests that BET, combined with MM, demonstrated superiority over MM alone, along with its safety, in treating dilatory ET dysfunction in patients with COM.