Abstract
OBJECTIVES: Balloon eustachian tuboplasty (BET) is an emerging treatment for dilatory eustachian tube (ET) dysfunction, yet its efficacy in patients with chronic suppurative otitis media (COM) combined with ET dysfunction remains unclear. This trial aimed to evaluate the efficacy and safety of BET versus medical management (MM) alone in adult patients with COM and chronic dilatory ET dysfunction, as defined by a failed Valsalva maneuver. METHODS: This prospective, multicenter, randomized controlled trial enrolled 116 participants (121 ears) between January 2021 and June 2023. Participants were randomly assigned (1:1) to receive either BET combined with MM or MM alone (fluticasone furoate nasal steroid spray). The primary short-term outcome was the normalization of the Valsalva maneuver at 8 weeks, while secondary outcomes included improvements in Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores and reductions in the air-bone gap (ABG) measured at 8 weeks. Adverse events were monitored in both groups throughout the follow-up period. RESULTS: Of the 116 participants (121 ears), 60 participants (62 ears) received BET and 56 participants (59 ears) received MM alone. There were no significant differences in demographics, baseline characteristics, ETDQ-7 scores, bone conduction thresholds, or ABG between the groups. In the BET group, 46.8% of ears (29/62) achieved a successful Valsalva maneuver compared with 15.3% of ears (9/59) in the MM-only group (P<0.001). The BET group exhibited greater subjective symptom improvement, with an average ETDQ-7 score reduction of -6.2±9.4 compared to -2.6±8.6 in the MM-only group (P=0.028). Additionally, the ABG decreased more significantly in the BET group (-5.8±11.4 dB HL) than in the MM-only group (-1.2±10.5 dB HL) (P=0.023). No serious procedure- or device-related adverse events were observed during the 8-week follow-up. CONCLUSION: This trial demonstrates that BET combined with MM is superior to MM alone in treating dilatory ET dysfunction in patients with COM, while also maintaining a favorable safety profile.